RCT of Two Antenatal Care Models in Rural Zimbabwe

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Randomised controlled trial of two antenatal caremodels in rural ZimbabweF Majoko,a SP Munjanja,b L Nystrom,c E Mason,d G Lindmarka

a Department of Womens & Childrens Health, Section for International Maternal & Child Health, Uppsala University, Uppsala, Swedenb Department of Obstetrics & Gynaecology, University of Zimbabwe Medical School, Harare, Zimbabwe c Department of Public Health &

Clinical Medicine, Epidemiology & Public Health Sciences, Umea University, Umea, Sweden d World Health Organization Country Office,

Harare, Zimbabwe

Correspondence: Dr F Majoko, Department of Obstetrics and Gynaecology, Singleton Hospital, Sketty Lane, Swansea SA2 8QA, UK.

Email: [email protected]

Accepted 4 February 2007.

Objective To compare a five-visit antenatal care (ANC) model

with specified goals with the standard model in a rural area in

Zimbabwe.

Design Cluster randomised controlled trial with the clinic as the

randomisation unit.

Setting Primary care setting in a developing country where care

was provided by nurse-midwives.

Population Women booking for ANC in the clinics were eligible.

Main outcome measures Number of antenatal visits, antepartum

and intrapartum referrals, utilization of health centre for delivery

and perinatal outcomes.

Methods Twenty-three rural health centres were stratified prior to

random allocation to the new (n = 11) or standard (n = 12) model

of care.

Results We recruited 13 517 women (new, n = 6897 and standard,

n = 6620) in the study, and 78% (10 572) of their pregnancy

records were retrieved. There was no difference in median

maternal age, parity and gestational age at booking between

women in the standard model and those in the new model. The

median number of visits was four for both models. The proportion

of women with five or less visits was 77% in the new and 69% in

the standard model (OR 1.5; 95% CI 1.082.2). The likelihood

of haemoglobin testing was higher in the new model (OR 2.4;

95% CI 1.05.7) but unchanged for syphilis testing. There were

fewer intrapartum transfers (5.4 versus 7.9% [OR 0.66; 95%

CI 0.440.98]) in the new model but no difference in antepartum

or postpartum transfers. There was no difference in rates of

preterm delivery or low birthweight. The perinatal mortality was

25/1000 in standard model and 28/1000 in new model.

Conclusion In Gutu district, a focused five-visit schedule did not

change the number of contacts but was more effective as expressed

by increased adherence to procedures and better use of

institutional health care.

Keywords Antenatal care, number of visits, pregnancy outcome,

rural Zimbabwe.

Please cite this paper as: Majoko F, Munjanja S, Nystrom L, Mason E, Lindmark G. Randomised controlled trial of two antenatal care models in rural Zimbabwe.

BJOG 2007;114:802811.

Introduction

There has been little change to the schedule of antenatal visits

that was recommended by the British Department of Healthin a 1929 circular which set out the timing of visits as every 4

weeks from booking until 30 weeks, every 2 weeks between 30

and 36 weeks and then weekly until delivery. Increased aware-

ness regarding the value of antenatal care (ANC) results in

women initiating care early, thus an average of 14 visits if the

standard model is implemented. The majority of women have

an uncomplicated antenatal course and would therefore have

received excessive, probably unnecessary, care. Epidemiolog-

ical studies suggest that ANC is beneficial in that women with

no ANC have poor pregnancy outcomes compared with

women with some ANC, and those with inadequate ANC

have poorer outcomes compared with women with adequatecare.13 Questions about the appropriateness of the current

ANC model for low-risk women have arisen in the past three

decades.49 The questions have been directed at the number of

visits and at whether all procedures performed at routine

visits were necessary and based on evidence for effective-

ness.1015 This has resulted in recommendations of modified

ANC models with reduced frequency of visits and only those

procedures considered effective. A large multicentre trial

802 2007 The Authors Journal compilation RCOG 2007 BJOG An International Journal of Obstetrics and Gynaecology

DOI: 10.1111/j.1471-0528.2007.01372.x

www.blackwellpublishing.com/bjogGeneral obstetrics


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coordinated by World Health Organization (WHO) in four

middle-income countries confirmed the safety of a reduced

visit programme.16 However, this trial was in urban or peri-

urban centres and did not include sub-Saharan Africa where

reproductive morbidity is high.

A randomised controlled trial conducted in Harare, Zim-babwe, confirmed that a reduction in number of visits and

change of routines were not associated with adverse maternal

or perinatal outcomes.17 However, in Zimbabwe, as in most

African countries, the majority of the population live in a rural

setting, and there are major differences between urban and

rural communities in availability, accessibility and utilisation

of health facilities.18 The results from the study in an urban

area in Zimbabwe therefore needed to be confirmed in a rural

setting prior to implementation of the recommendations at

national level. Furthermore, the urban study had looked at

a low-risk population as only uncomplicated pregnancies

were booked in the clinics, whereas in rural areas, all women

attend the same health centres, making risk assessment and

appropriate referral crucial.

The primary objective of this study was to compare two

ANC models in a rural population in Zimbabwe. Our null

hypothesis was that in a rural unselected population, an ANC

model with five planned visits and goal-oriented routines was

as effective as the standard model, where effectiveness was

measured by utilisation of health facility for ANC and child-

birth, referrals to the district hospital and the fetal outcomes

of preterm birth and low birthweight.

Materials and methods

This was a cluster randomised controlled trial (RCT) where

the health facility was the unit of randomisation. The cluster

design was chosen for practical reasons, as effective individual

randomisation was not possible in this setting. It would not

have been feasible for nurse-midwives to give alternative

models of care to randomly allocated women in individual

health centres. The control arm of the study used the tradi-

tional ANC model that was the standard for the country. The

experimental arm introduced a five-visit model with defined

goals for each visit (Table 1).

Gutu district was chosen as the study area because the

utilisation of maternity services19 and reproductive health

status of the community had been previously studied.20 The

district had 25 health facilities, comprising a district hospitaland 24 rural health centres (RHCs) serving a population of

195 000. The normal practice was for women to register for

care at the nearest health facility. Utilisation of the RHCs for

ANC was high, with 9497% of women attending at least once

during the pregnancy, but the use of the health facilities for

delivery was low at 7785%.1921 A survey conducted prior to

the trial revealed a median number of seven antenatal visits in

the district.19 Of the 25 health facilities in the district, two

were excluded from the RCT because of their function as

referral centres and geographical location at the commercial

centre of the district (Gutu Mission Hospital and Gutu Rural

Hospital). The remaining 23 health facilities were stratified

by availability of radio telecommunication facilities and/or

maternity waiting shelter and then allocated by simple

randomisation within strata to the new (n = 11) or standard

(n = 12) model (Figure 1). The health facilities were stratified

according to the availability of radio telecommunication as

this had an impact on ease of communicating with the district

hospital in the event of an intrapartum referral.

The planning of the study was performed in collaboration

with the Masvingo Provincial Medical Director and discussed

with the doctors working in the district hospital. Preparatory

meetings were held with community and opinion leaders in

the district to inform them about the study. It was not pos-

sible to offer choice and an alternative to individual women asrandomisation was at health facility level. However, women in

RHCs that implemented the new model were informed about

the study and the schedule of visits at the booking visit.

Women were also informed that additional visits would be

arranged if they felt the need to attend more frequently than

the suggested schedule or if pregnancy complications devel-

oped. Women were asked for verbal consent to use data from

their pregnancy records. The Medical Research Council of

Table 1. Timing and content of antenatal visits for new model

Visit number Gestation

age (weeks)

Goal Procedures*

1 ,20 (ideal) Risk assessment, health education and delivery plan Haemoglobin, rapid plasma reagin,

tetanus vaccination and urinalysis

2 2428 Exclude multiple pregnancy and check for hypertensive disorders Urinalysis**

3 3234 Exclude anaemia, check fetal growth and review delivery plans Haemoglobin and urinalysis**

4 3638 Check fetal growth, exclude abnormal presentation, discuss labour Urinalysis**

5 4041 Check fetal wellbeing, referral for post-term induction at 42 weeks Urinalysis**

*Blood pressure and symphysis fundus height were measured at each visit.

**If blood pressure 140/90.

Antenatal care in rural Zimbabwe

2007 The Authors Journal compilation RCOG 2007 BJOG An International Journal of Obstetrics and Gynaecology

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Zimbabwe and the Medical Research Ethics Committee ofUppsala University approved the study.

The control arm followed the standard schedule with a visit

every 4 weeks from booking until 28 weeks, every 2 weeks

between 28 and 36 weeks and weekly after 36 weeks until

delivery. Risk assessment was performed at the booking and

subsequent visits, and referral for hospital delivery was made

using a list of risk markers recommended by the Zimbabwe

Ministry of Health and Child Welfare. Blood pressure, body

weight and urinalysis were measured at each visit, while

haemoglobin and syphilis test (rapid plasma reagin) were

performed at the first visit. The use of a rapid test meant

that women who tested positive for syphilis had treatment

initiated at the booking visit. Oral iron supplementation

was provided to all women in both models. The experimental

arm implemented a modified programme (Table 1) with a

new visit schedule, revised procedures with clear goals and

symphysiofundal height measurement in screening for

multiple pregnancy and abnormal fetal growth.

Before the trial, nurse-midwives from all RHCs partici-

pated in workshops to upgrade their knowledge and skills

about the ANC model they would implement. All RHCs were

supported and supervised by the same team during the trial.

To ensure that differences in outcomes were not related to

differences in resources, RHCs were supplied with equipment

to perform all procedures as in the protocol. There wereno additional personnel introduced into the RHCs for the

purpose of the trial. The women and care givers were aware

of their allocated care model.

Primary outcomes were chosen for their ability to assess

effectiveness and quality of service and included number of

visits, referrals from RHC for antenatal, intrapartum or post-

partum problems, place of delivery and low birthweight

infant (


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analyses were by intention to treat and accounted for the

within-clustercorrelation. As thiswas an equivalence trial, effi-

cacy analyses were conducted comparing the two models using

the standard model as a reference. Rate difference (RD) and

odds ratio with 95% confidence intervals were adjusted for the

cluster randomisation. The analysis was performed using

ACLUSTER for a stratified design, with comparison of propor-

tions according to the method described by Donner and Klar.22

Results

There were 13 517 women recruited from January 1995 to

October 1997. Pregnancy records were retrieved from 10 572

women (78%), and maternal and neonatal outcomes were

known in a further 2651 women (20%), but in 2% of women,

there was no information on maternal and fetal outcomes

(Figure 2). There was no difference in age, parity and gesta-

tional age at booking by cluster and by model (Table 2).

There was no difference by maternal risk factors (young/old

age, late booking [>28 weeks], nulliparity/multiparity andprevious pregnancy complications) (Table 3). The mean

haemoglobin at booking was 11.7 g/dl and 12.1 g/dl in the

standard and new models, respectively.

A box plot of number of visits by RHC (cluster) and model

is presented in Figure 3 illustrating a homogeneous pattern.

In the new model, 9 of 11 and in the standard model, 8 of 12

clusters had a median of four visits, resulting in a median of

four visits in both models. The likelihood of making five or

fewer visits was significantly increased in the new model, RD

84 (95% CI 1.4169). In the standard model, only 11%

(236/2111) of women booking before 20 weeks had the speci-

fied minimum of nine antenatal visits. In the new model,

however, 42% (945/2236) of women booking before 20 weeks

had the specified minimum of five visits. The likelihood of

having their haemoglobin checked at booking was increased

in the new model (RD 118; 95% CI 3.8233), but there was no

effect on the rate of syphilis testing (RD 71; 95% CI 2.5 to

145) (Table 4). Almost all women (97.3%) who tested posi-

tive for syphilis received treatment at their first visit, with the

remainder treated later in the pregnancy. In both models, the

blood pressure was checked in 99% of women at the booking

visit, and this high level of performance was consistent at

subsequent visits.

Fundal height measurement was included only in the new

model and was performed in 84% of the women during 77%

of visits. The prevalence of fundal height measurementwas around 85% in visits 13 but decreased to 76, 61 and

45% in visits 4, 5 and 6, respectively. Six percent (273/4488) of

fundal height measurements at the first visit were large for

dates. Fifty-seven of these women (21%) were referred as

suspected multiple pregnancies, out of which 32 (56%)

were confirmed. The proportion of women diagnosed with

Randomised(N = 13 517)

Standard model(n = 6620)

New model(n = 6897)

Pregnancy loss


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a breech presentation (54 versus 63%) or twin pregnancy(41 versus 43%) was low in both the standard and new

models, respectively, and was not significantly different.

There was no difference in the prevalence of antepartum

and postpartum referrals (Table 4). However, the risk of

intrapartum referral was significantly reduced in the new

model (RD 25; 95% CI 49 to 1.4). There were fewer

women from the new model who delivered at home

(RD 60; 95% CI 153 to 34) or at the district hospital

(RD 62; 95% CI 154 to 30), but these differences werenot statistically significant.

There was no significant difference in rates of preterm

delivery, low birthweight and perinatal death between the

two models (Table 5). The mean gestational age at delivery

was 38 weeks for both the models. There was no difference in

mean birthweight, 3134 g (SD 478) and 3169 g (SD 506) for

standard and new models, respectively. The perinatal mortal-

ity rate was similar, 25/1000 and 28/1000 for standard and

new models, respectively.

There was no difference in the detection of hypertensive

disorders of pregnancy between the models, RD 7.9 (95% CI

3.6 to 19.4). The likelihood of operative interventions was

reduced in the new model, RD 9.2 (95% CI 1.4 to 17.0),

but the difference was not significant when adjusted for

cluster (Table 5).

There were six maternal deaths (two in the standard model

and four in the new model), thus giving a maternal mortality

rate of 45/100 000 pregnancies. In two deaths (one in each

model), there was insufficient information to attribute a cause,

as the maternal record was not available. The second woman

in the standard model died from postpartum haemorrhage

after a home birth at 36 weeks. In the new model, one woman

died from puerperal sepsis associated with HIV infection after

a preterm delivery in a RHC. Two further women in the new

model died after home births, one from postpartum haemor-rhage and the other from sepsis. The maternal deaths could

not be attributed to any factors related to the ANC received.

Discussion

In this cluster randomised trial, a modified antenatal

programme was introduced in a rural African setting

where women booked late, staff had a number of other

Table 2. Median age (years), parity, gestational age (weeks) at booking in the standard and new models by cluster

Cluster number Standard model New model

Number of women Age Parity Gestational age Number of women Age Parity Gestational age

1 453 24 1 23 251 24 1 20

2 491 23 1 23 413 24 1 213 1282 25 1 22 1291 24 1 24

4 238 24 1 21 421 24 2 22

5 1084 24 1 21 1074 24 1 21

6 547 24 1 21 1046 24 1 21

7 932 25 1 22 712 24 1 20

8 170 23 1 20 218 24 1 23

9 346 24 1 22 419 24 1 21

10 593 25 2 24 505 24 1 21

11 170 24 1 21 547 24 1 22

12 314 23 1 21

Total 6620 24 1 22 6897 24 1 22

Table 3. Maternal characteristics at booking in the standard and

new models for women with retrieved pregnancy records

Characteristic Standard model

(n 5 5223)

New model

(n 5 5349)

Ratio % Ratio %

Age (years)

19 815/5193 15.7 8714/5311 16.9

35 742/5193 14.3 714/5311 13.4

Parity

0 1618/5222 31.0 1734/5346 32.4

6 389/5222 7.4 388/5346 7.3

Gestational age at booking (weeks)

20 2122/5028 42.2 2235/5229 42.7

29 843/5028 16.8 931/5229 17.8Haemoglobin at booking (g/dl)

11 3267/4052 80.6 4270/4782 89.3

Previous pregnancy complications (multiparous women only)

Stillbirth 123/3604 3.4 125/3613 3.5

Preterm birth 115/3604 3.2 130/3613 3.6

Neonatal death 119/3604 3.3 123/3613 3.4

Caesarean section 174/3604 4.8 153/3613 4.2

Any complication 531/3604 14.7 531/3613 14.7

Majoko et al.



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responsibilities, transport both to the primary clinic and to

higher level of care was often difficult and resources to care for

complications at the primary level were limited. The new

model aimed to provide similar or more effective care than

the standard model through clear goals in a limited number of

planned visits. To our knowledge, this is the only reported

RCT of an ANC model implemented in a rural setting from

sub-Saharan Africa.

Minimising loss to follow up is a major challenge to con-

ducting a large trial in a rural African setting. The population

of pregnant women was mobile, and therefore, there was

a high rate of failure to retrieve the pregnancy records because

of migration and home births. Women sometimes received

care in more than one geographical area during a pregnancy.

Some women joined their husbands in the urban centres and

gave birth in an urban health facility. We consider a complete

follow up of 78% of women and information on crude out-

comes in a further 20% under the circumstances in which the

study was conducted as acceptable. The baseline booking data

for the 22% of women whose records were not retrieved were

similar to the data of those with complete information, and

there is no reason to assume that their outcomes would have

been significantly different. Problems with retrieval of preg-

nancy records have been experienced with similar trials in

Zimbabwe where only 49% of records were retrieved.23

Nurse-midwives providing ANC had other primary care

Table 4. Stratified cluster analysis of antenatal procedures and utilisation of health facilities

Characteristic New model Standard model ICC RD Adjusted 95% CI OR Adjusted 95% CI

Ratio Rate/1000 Ratio Rate/1000

Number of visits 5 4106/5327 771 3561/5182 687 0.041 84 1.4 to 169 1.5 1.082.2

Syphilis testing 4697/5349 878 4214/5223 807 0.047 71 22.5 to 145 1.7 0.973.1

Haemoglobin check 4782/5349 894 4052/5223 776 0.112 118 3.8 to 233 2.4 1.005.7

Place of delivery

Home or in transit 964/5261 183 1248/5137 243 0.059 260 2153 to 34 0.70 0.401.2

Health centre 2660/5261 506 1986/5137 387 0.103 119 230 to 268 1.7 0.883.0

District hospital 1499/5261 285 1782/5137 349 0.044 262 2154 to 30 0.75 0.491.2

Referrals

Antepartum 1531/5349 286 1558/5223 298 0.036 212 2101 to 64 0.94 0.621.4

Intrapartum 283/5261 54 406/5136 79 0.0091 225 249 to 21.4 0.66 0.440.98

Postpartum 45/5257 8.6 29/5129 5.7 0.0068 22.9 24.3 to 10 1.5 0.534.3

CI, confidence interval; ICC, intracluster coefficient; OR, odds ratio.

CIs are adjusted for cluster randomisation.

Clinic number

1110987654321

Numberof

visits

12

10

8

6

4

2

0

Clinic number

121110987654321

Numberof

visits

12

10

8

6

4

2

0

Standard model New model

Figure 3. Box plots for number of visits in each clinic in the standard and new models.



807


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responsibilities for which there were performance targets that

were directly supervised. They had to prioritise between sev-

eral competing programmes and were not always inclined to

adhere to a programme with a message towards changing

established practices. Trial contamination is always a danger

when different programmes are implemented in the same

area. Nurse-midwives in the district had monthly meetings,

and it is likely that aspects of the study were discussed among

staff implementing the different models. Another factor was

the resistance from the mothers to changes in a programme

that was well established and accepted.24,25 Some women,

especially those who were nulliparous or of low parity, were

not supportive of changing the spacing of visits. They felt that

fewer contacts with nurse-midwives could reduce chances of

detecting pregnancy complications and that their needs for

reassurance could not be met.

Although individual randomisation would have been ideal,

it was not considered feasible in this rural setting. There

would have been problems associated with randomisationof women to receive different types of care from the same

nurse-midwives. Cluster design has been used in similar

ANC trials.5,16,17

The number of women who had equal to or less than the

recommended visits in the new model was increased, which

indicates that women who booked late were seen according to

the protocol. However, in the standard model, the median

number of visits decreased during the trial compared with

what was reported before.19 The modest decrease in the pro-

portion of women with more than six visits in the new model

confirms that even in a setting where the number of visits

could already have been considered low, it is possible to make

further reduction through a focused programme. In this set-

ting with late initiation of ANC, a large reduction in number

of antenatal visits was unlikely, and emphasis was on the value

of a focused programme in which the number of visits was

determined by the womans clinical needs. Previous unsuc-

cessful efforts to reduce the number of antenatal visits have

been reported in several trials and are ascribed to resistance to

change by women and their carers.5,2530 However, the WHO-

coordinated multicentre and Harare trials were successful in

reducing visits among low-risk women.16,17

The increased emphasis on clear goals for each contact with

the pregnant woman resulted in a better adherence to perfor-

mance of well-known standard procedures such as haemoglo-

bin measurement or syphilis testing. It has been demonstrated

that poor quality in routine ANC is common in low-resourcesettings.18,31 The poor quality of care is partly attributed

to high volume of work, limited resources, insufficient

manpower and lack of resources for management of compli-

cations. Health personnel lacking understanding of the signif-

icance of the procedures, poor supervision and feedback also

contribute to poor quality of care. Compliance with new

components such as fundal height measurement was low,

probably because of staff perception. The intended benefits

Table 5. Maternal and neonatal outcomes in new and standard models with ratio, rate, RD and OR with 95% CI

Characteristic New model Standard model RD 95% CI OR 95% CI

Ratio Rate/1000 Ratio Rate/1000

Maternal complications

Hypertensive disorders 492/5324 92.4 522/5204 100.32

7.92

3.6 to 19.4 0.91 0.801.04Eclampsia 3/5238 0.6 12/5126 2.3 21.7 20.1 to 23.4 0.24 0.050.93

Antepartum bleeding 9/5239 1.7 12/5126 2.3 20.6 22.6 to 1.3 0.73 0.291.86

Operative delivery 190/5232 36.3 233/5118 45.5 29.2 21.4 to 217.0 0.79 0.650.97

Postpartum haemorrhage 34/5238 6.5 34/5123 6.6 0.1 23.2 to 3.5 0.98 0.591.62

Maternal death 4/6696 0.6 2/6483 0.3 0.3 212 to 6.0 1.94 0.3115.2

Fetalneonatal

Preterm delivery

(,37 weeks)

599/5058 118.4 588/4930 119.3 20.9 213.8 to 12.0 0.99 0.881.12

Birthweight,2500 g 267/4280 62.4 227/3834 59.2 3.2 213.9 to 7.5 1.06 0.881.27

Birthweight,1500 g 25/4280 5.8 22/3834 5.7 0.1 23.7 to 3.4 1.02 0.551.88

Fetal and neonatal mortality

Stillbirth 63/5242 12.0 69/5105 13.5 21.5 26.0 to 3.0 0.89 0.621.27

Stillbirth 36 weeks 36/5242 6.9 27/5105 5.3 1.6 21.6 to 4.8 1.30 0.772.21

Stillbirth .36 weeks 24/5242 4.6 37/5105 7.2 22.6 25.8 to 0.5 0.63 0.361.08

Early neonatal death 19/5242 3.6 15/5105 2.9 0.7 23.1 to 1.7 1.23 0.602.56

Late neonatal death 49/4173 11.7 35/3941 8.9 2.8 21.8 to 7.4 1.33 0.842.10

Perinatal death 185/6614 28.0 161/6384 25.2 2.8 22.9 to 8.5 1.11 0.891.39

CI, confidence interval; OR, odds ratio.

Majoko et al.



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of this method can be difficult to bring across, and there are

no studies that show improved perinatal outcome from its use

in settings similar to that of Gutu, where follow-up investi-

gations for confirming a diagnosis of abnormal fetal growth

or for monitoring the fetal condition are not available. Pre-

vious studies in Africa have mainly discussed fundal height

measurement as cheap and easy to perform but not the

necessary resources for follow up of abnormal findings, even

though in some affluent settings, more elaborate technologies

will be available.3235 Fundal height measurement has low

sensitivity and specificity, necessitating further investigation

such as ultrasound which is not available in many low-

resource settings. The diagnostic ability for twin pregnancy,

which this method should increase, did not change in either

of these trials. This is partly because of the low referral rate of

those found to have abnormal measurements. Better educa-

tion of the midwifery staff is clearly important, although

change may be difficult to achieve in midwives who have been

practising the same way for many years. It seems that the best

place to introduce new activity such as fundal height measure-ment is into the initial training of midwives and other staff.

There is evidence that the clear recommendation to discuss

and counsel women on place of delivery had an effect. Health

facility delivery was increased in the new model, and there was

more appropriate use of RHC for delivery. The trial used

revised referral criteria for the new model, but there was no

difference in antepartum referrals. The significant reduction

in intrapartum referrals in the new model was not associated

with an increase in either postnatal referrals or neonatal mor-

bidity. There was also a reduction in home births for women

in the new model. This confirms that discussing about deliv-

ery several times during antenatal visits and encouraging

women to make use of the health centre for delivery can

successfully reduce unsupervised home deliveries. This can

be expected to have a positive impact on both maternal and

perinatal outcomes.

A major concern with reduced-visits programmes might be

failure to detect or late detection of complications such as

hypertensive disorders of pregnancy because of decreased

contacts. Failure to detect severe pre-eclampsia could be

reflected in an increased number of women experiencing

complications of severe hypertension such as eclampsia.

Reduced detection of hypertension has been reported in pre-

vious reduced-visits programmes,16,17,36 but other trials have

found no difference in detection of complications.26,27 In thisstudy, there was no difference seen in the rate of observed

hypertensive disease. The eclampsia rate was lower in the new

model, but the difference was not significant when adjusted

for cluster design.

Ideally, this trial would have been powered to assess equiv-

alence in fetal and maternal morbidities between the groups,

but this was not feasible with the resources available to us.

Hence, we had to rely on process indicators for our outcome

measures. The problem with this is that significant differences

may be detected in process indicators when in fact there is no

difference in important outcomes.

Conclusion

This was a pragmatic trial assessing ANC in practice and thefeasibility of introducing change through a modified schedule

of visits and procedures. Process outcomes were improved in

the new model with less emergency referrals during labour

and with more women delivering at health institutions with

trained staff without an increase in operative delivery. The

new model appears suitable for implementation in other set-

tings as it is associated with efficient use of a limited number

of visits. It remains to be seen whether this reduced-visit

schedule has any effect on maternal or fetal morbidity.

AcknowledgementsThe ANC study in Gutu was funded by the Swedish Inter-

national Development Cooperation Agency (Sida/SAREC)

through the SidaUniversity of Zimbabwe Reproductive

Health Research Programme. We thank all the women who

participated in the trial for their willingness to cooperate and

the health personnel in the district for their cooperation,

despite the increased demands on their limited time. The sup-

port received from the Provincial Medical Director, District

Medical Officer and District Nursing Officers was important

for the successful conduct of the study. j

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Commentary on Antenatal care programmes inlow resource settings

Dr Majoko et al. report a cluster randomised controlled trial of a goal-oriented antenatal care model with the aim of better

targeted but fewer visits in a rural setting. In Zimbabwe, as in many other parts of Africa, late booking and missed antenatal

visits are common, and for this reason, it is not surprising that there were similarly small numbers of visits in the standard

and the new care models. Having complete data on 78% of women is reasonable considering the setting with mobility of the

population. Having crude follow-up data on 98% of women is a remarkable achievement. The new model aimed to deliverspecific interventions and procedures at each visit. Haemoglobin and syphilis testing coverage were improved in the new

model, although the change in the latter was not statistically significant. The authors report that women were anxious about

the reduction in number of visits, although data on the womens views were not systematically reported. Clinicians working

in settings where hypertensive disorders of pregnancy are a common cause of maternal mortality and morbidity have

expressed concern that 4-week spacing of visits after 32 weeks may fail to detect the onset of pre-eclampsia in time to

prevent serious complications. A possible alternative, which has not been tested to our knowledge, is to teach pregnant

women to do weekly urine testing at home. It might also be argued that clinic testing for proteinuria only when

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hypertension is detected, as in the current trial protocol, will fail to identify the less common but serious occurrence of

gestational proteinuria preceding hypertension. However, the data on the occurrence of eclampsia in the current trial are

reassuring.

The Cochrane review (Villar et al. Patterns of routine antenatal care for low-risk pregnancy. Cochrane Database Syst Rev

2001) on antenatal care models includes two trials conducted in developing country settings. The first trial was conducted

in urban Zimbabwe by the same group of researchers who conducted the rural Zimbabwe trial reported here (Munjanja

et al., Lancet 1996;348:3649). The second trial is the World Health Organization Antenatal Care trial conducted inArgentina, Cuba, Thailand and Saudi Arabia (Villar et al., Lancet2001;357:155164). The main conclusion of the Cochrane

review is that fewer but goal-oriented visits have similar clinical outcomes to traditional frequencies and cost less, although

they may result in some women feeling that they do not receive adequate care. Antenatal care programmes should have

specific goals, and the activities needed to reach those goals should be communicated clearly to caregivers. The minimum

antenatal care package content is relatively clear. In different settings, there may be a need to include other activities based

on epidemiological factors and local priorities. A particular problem in developing country settings, highlighted again in

this report, is the lack of early antenatal booking to establish gestational age, treat syphilis, institute dietary supplementation

and identify women requiring antiretroviral treatment. Research in South Africa has shown that many women access health

services early in pregnancy for pregnancy confirmation, but these opportunities to institute formal antenatal care are not

used, and when the women book much later in pregnancy, early pregnancy information is not available (Jeffery et al., S Afr

Med J 2000;90:1536). A possible solution is to promote a policy whereby every pregnant woman attending a private or

public health facility for the first time, even if not at a formal antenatal clinic, is offered the first visit package described inthis trial and issued with a patient-held pregnancy record on which the early visit information is recorded. As with any

practice, the implementation of a goal-oriented antenatal care programme should be audited. Such audit may be more

important for a complex intervention such as an antenatal programme where several individual activities need to be tracked

and to avoid ending up with a programme that contains the same old rituals in fewer visits. j

A Metin Gulmezoglu* and G Justus Hofmeyr

*The author is a staff member of the World Health Organization. The author alone is responsible for the views expressed in this publication and they do not

necessarily represent the decisions or the stated policy of the World Health Organization.



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RCT of Two Antenatal Care Models in Rural Zimbabwe