Material y métodos
5. DETERMINACIONES BIOQUÍMICAS
The data presented in Table 23 correspond to the 1101 women (and their babies) who were successfully followed up at 3 months postpartum (560 from the intervention group and 541 from the control group). Data for an additional 31 women and their babies, who were followed up at 8 months but not at 3 months (16 from the intervention arm and 15 from the control arm), was available on twin births, newborn deaths and deaths of women. This data were therefore added to the denominator for these outcomes.
There was no predefined primary or secondary outcome related to this thematic area.
The data show that the number of ANC consultations attended was similar in both arms of the trial, with approximately 75% of women attending 3 or 4 consultations. The majority of participants gave birth in a study PHC, slightly more in the intervention group (68%) compared to the control group (63%). By far the second most common location of birth were referral hospitals, where about a quarter gave birth in both arms. Vaginal birth was almost universal, with only 3% giving birth by Caesarean in either arm. No women reported having an operative vaginal birth. Twin births occurred for 2% of women in both groups. The sex ratio at birth was almost equally split between male and female infants in both arms. Just over half of women were discharged from the health facility the day after birth (55%) in both arms, whereas about 40% were discharged on the day of birth itself.
Approximately 3% of newborns were stillborn or died within a week of birth in both arms, with 7 babies dying later in the control arm, versus one in the intervention arm. Data on prematurity is not presented here, because of imprecise gestational age assessment combined with a lack of reporting. We were also unable to ascertain whether the stillbirths occurred antepartum or intrapartum.
147 Three deaths occurred among women who were participants in the study, two from the
intervention arm and one from the control arm. Despite our attempts to find out further details from the interviewers who spoke to their families, the circumstances of their deaths remain unclear. The deaths occurred postnatally. Two women died prior to the 3-month follow-up, whereas the third died after having been interviewed at 3 months but before the 8-month follow- up.
Table 23: Birth outcomes and maternal and newborn health
Intervention (n=560) Control (n=541) Number of ANC consultations attended: n
[%] 1 4 [0.7] 6 [1.1] 2 37 [6.6] 43 [8.0] 3 183 [32.7] 170 [31.4] 4 244 [43.6] 249 [46.0] 5 or more 92 [16.4] 73 [13.5] Location of birth: n [%] Study PHC 379 [67.7] 339 [62.7] Other public PHC 17 [3.0] 27 [5.0] Referral hospital 139 [24.8] 145 [26.8] Private clinic 13 [2.3] 12 [2.2]
Home or other non-facility 12 [2.1] 18 [3.3]
Mode of birth: n [%] Vaginal 543 [97.0] 524 [96.9] Caesarean section 17 [3.0] 17 [3.1] Twin births: n [%] ¹ 12 [2.1] (n=576) 13 [2.3] (n=556) Sex of baby: n [%] ² ³ Female 274 [50.1] 278 [52.0] Male 273 [49.9] 257 [48.0]
Discharge day after birth: n [%] 4
Same day 220 [40.2] 201 [38.4]
Next day 303 [55.3] 290 [55.5]
2 days later or more 25 [4.6] 32 [6.1]
Newborn deaths: n [%] ¹ ³
Perinatal deaths (incl. stillbirths) 20 [3.5] (n=576) 18 [3.2] (n=556) Late neonatal deaths (8-27 days pp) 0 [0.0] (n=576) 4 [0.7] (n=556) Infant deaths (>=28 days pp) 1 [0.2] (n=576) 3 [0.5] (n=556) Deaths of women: n [%] ¹ 2 [0.4] (n=576) 1 [0.18] (n=556)
¹ Combined denominator including all women followed up at at least one of the two follow-up rounds ² Missing for 19 women (13 from the intervention arm and 6 from the control arm), all of whom had a stillbirth.
148
³ Data presented applies only to first twins, in the case of twin births.
4 Women who had non-facility births (12 from the intervention arm and 18 from control) excluded
9.2.
Postnatal care
The results presented in this Subchapter are based on data from the 1101 women who were successfully followed up at 3 months postpartum (560 from the intervention group and 541 from the control group).
9.2.1. PRIMARY OUTCOME A.: Attendance at scheduled PNC (at least 2
consultations)
As described in the Subchapter 5.3.1, Primary outcome a. was defined as the proportion of women attending the scheduled outpatient PNC consultations (at least 2, normally at 6 days and at 6 weeks postpartum).
Table 24 shows that, for the whole sample, the proportion of women attending at least two PNC consultations was higher, at 61%, in the intervention arm, compared to 49% in the control arm. A binomial regression, adjusting by recruitment PHC, found a Risk Difference (RD) of 11.7 percentage points between the two arms, with strong evidence for this effect (95% C.I. 6.0-17.5, p<0.001). This suggests that the intervention increased the uptake of outpatient PNC
consultations.
A stratified analysis by recruitment PHC was also run, using binomial regression. This shows that the direction of effect was positive in all health centres, although there was strong evidence of an effect only in Sarfalao, some evidence in Bolomakote, and low or no evidence in the other PHCs. The Likelihood Ratio Test produced no evidence of effect modification by recruitment PHC for this outcome (p=0.734).
Table 24: Summary and stratified result estimates for Primary outcome a. Attendance at scheduled PNC (at least 2 consultations)
Intervention: n [%] Control: n [%] RD adjusted by PHC: [%] 95% C.I. - upper bound: 95% C.I. - lower bound: P-value
Summary estimates (whole sample): 342 [61.1] 265
[49.0]
11.7 6.0 17.5 <0.001
Estimates stratified by recruitment PHC:
Bolomakote 48 [53.9] 33 [38.8] 15.1 0.5 29.8 0.043
Guimbi 65 [68.4] 66 [62.9] 5.6 -7.6 18.7 0.407
Ouezzinville 81 [52.9] 68 [43.3] 9.6 -1.5 20.7 0.088
Sarfalao 87 [75.7] 51 [58.0] 17.7 4.7 30.7 0.007
Secteur 24 61 [56.5] 47 [44.3] 12.1 -1.2 25.4 0.074
149
9.2.2. PNC – further detail
As shown in Table 25, a slightly larger majority of women had a postpartum check-up prior to being discharged in the intervention group (60%) compared to the control group (55%). A more detailed breakdown of the number of outpatient PNC consultations attended is provided here. Reflecting the results shown above, there were noticeable differences between the two arms, including, in the intervention arm, fewer women not attending PNC at all (15% versus 23%), and more attending two consultations (61% versus 49%). The timing of PNC attendance in our sample is highly clustered around the two recommended times for PNC check-ups at 6 days and 42 days postpartum (data not shown).
Women who had attended PNC were asked what prompted them to go. Among attendants at the either PNC appointment, almost all reported that they had attended for a check-up. Very few women said they attended because they had a particular problem. Finally, up to 1 in 5 women attending the 2nd PNC visit said that they attended in order to get a contraceptive method. This
proportion was higher than for the 1st visit, and for both appointments it was higher in the
intervention group, compared to the control group. The study PHCs were overall the most popular location for PNC. Even among women who had given birth in a private clinic or referral centre, half of those who attended PNC attended their first appointment at a study PHC. Among these women, this proportion rises to over 90% for the 2nd appointment. There were no
150 Table 25: Postnatal care
Intervention (n=560) Control (n=541) Had postpartum check-up prior to discharge
(6th hour): n [%] 1
329 [60.0] 289 [55.3]
Number of outpatient PNC consultations attended: n [%]
None 83 [14.8] 124 [22.9]
1 135 [24.1] 152 [28.1]
2 341 [60.9] 263 [48.6]
3 or more 1 [0.4] 2 [0.4]
Reason for attending PNC (1st cons.) : n [%] 2, 3
Check-up 477 [100] (n=477) 416 [99.8] (n=417)
Problem with mother or baby 0 [0.0] (n=477) 2 [0.5] (n=417) To obtain FP method 18 [3.8] (n=477) 11 [2.6] (n=417) Place where attended PNC (1st cons.): n [%] 3
Study PHC 411 [86.2] (n=477) 348 [83.5] (n=417)
Other facility 66 [13.8] (n=477) 68 [16.3] (n=417)
Other (midwife’s house) 0 [0.0] (n=477) 1 [0.24] (n=417) Reason for attending PNC (2nd cons.): n [%] 2,4
Check-up 340 [99.4] (n=342) 264 [99.6] (n=265)
Problem with mother or baby 1 [0.3] (n=342) 0 [0.0] (n=265)
To obtain FP method 69 [20.2] (n=342) 45 [17.0] (n=265)
Place where attended PNC (2nd cons.): n [%]4
Study PHC 320 [93.6] (n=342) 240 [90.6] (n=265)
Other facility 22 [6.4] (n=342) 25 [9.4] (n=265)
1 Women who had non-facility births (12 from the intervention arm and 18 from control) excluded. 2 More than one response was possible.
3 Denominator corresponds to women who attended at least one consultation. 4 Denominator corresponds to women who attended at least two consultations.