Reduced perinatal mortality following enhanced training of birth attendants in the Democratic Republic of Congo: a time-dependent effect

A train-the-trainer educational program was developed using a variety of teaching methods, including clinical practice sessions and demonstrations. Supervisory personnel of the FIRST BREATH Trial trained two DRC Country Trainers. The supervisory personnel had extensive global health and educational experience, and specifically in instruction in both the ENC program and NRP. Country Trainers were general medical doctors with experience in rural health practice but no previous training in the ENC program or NRP. In a five-day workshop, the Country Trainers subsequently trained one Community Coordinator (CC), a professionally trained nurse, from each study community and the four physicians who staffed the district hospitals. In addition to instruction in the program content, these trainees were taught adult education methodologies. Thereafter, in a series of three-day workshops (one for each phase of the study; see below), the CCs and local physicians trained the practicing birth attendants within each community. Birth attendants included 152 TBAs and 18 nurses and nurse midwives. Nurses in the DRC typically complete four years of nursing education following ten years of primary and secondary education. Nurse midwives receive an additional three years of maternal and child health education. TBAs receive variable training, which is usually limited to an apprenticeship with an experienced TBA. They do not have formal education and are usually illiterate. Separate workshops were conducted for TBAs and for nurses and midwives. All workshops for each phase of the study were completed within one calendar month.

The study began with training in data collection and other basic study procedures, including evaluation of newborns, particularly the identification of vital signs to ensure the proper differentiation between stillbirths and live born infants. Scales for weighing newborns (Salter Scales; UNICEF model 145555) and disposable delivery kits (Population Services International, Washington, DC) were distributed at this time. Thereafter, a period of baseline data collection began.

After the period of baseline data collection, the train-the-trainer model was used to train all personnel in the ENC program[11]. The ENC program content included routine neonatal care, initiation of breathing and resuscitation, thermoregulation, early and exclusive breastfeeding, kangaroo (skin-to-skin) care, small baby care, recognition of danger signs, and recognition and initial management of complications. Resuscitation training was limited to recognizing the apneic infant and the use of stimulation and manual ventilation. Ventilation bags and face masks were distributed, and instruction in their use was provided. Educational materials, utilizing drawings in lieu of text, were developed for training of TBAs.

After an additional period of data collection, birth attendants in six randomly selected communities received more extensive resuscitation training using an adaptation of the NRP. This training also utilized a train-the-trainer model, and material that was adapted for the environment. This intensive basic resuscitation course included the initial steps of resuscitation and bag and mask ventilation, but excluded the use of oxygen, intubation, chest compression and the administration of drugs. In contrast to the resuscitation training in the ENC program, NRP training included a systematic approach to resuscitation that included repeated observations throughout the first few minutes following delivery and standardized responses to these observations. A refresher course was conducted six months after initial training.

Reinforcement of training occurred throughout the study at monthly meetings attended by CCs and birth attendants in each community. The CCs (the original trainers of the birth attendants) reviewed the ENC program in all communities. In addition, they reviewed the NRP in the intervention communities. The content of the meetings was left to the discretion of the CC, but in general was based on observations made during the supervision of the birth attendants' activities, including deliveries when possible. Deficiencies in care or gaps in knowledge were the focus of discussions at these meetings. Additional training was usually practical rather than theoretical and involved repetition of hands-on skills, for example, mannequins and bags and masks were used to practice resuscitation skills. Although we did not systematically record attendance, we estimate that more than 95% of birth attendants participated in these meetings.

CCs or birth attendants obtained consent (at the time of enrollment) and collected all data on standardized data forms. Community Health Workers assisted illiterate TBAs in the completion of these forms. Data forms were reviewed for accuracy by the CCs. Data edits, including inter- and intra-form consistency checks, were performed upon data entry locally and by the data coordinating center (RTI International, Research Triangle Park, NC, USA).

The number of communities selected from the DRC was determined by the sample size calculation for the FIRST BREATH Trial, and the number of deliveries observed was a function of the timing of the study periods for that trial[10].

The primary outcome for the analyses in this manuscript was perinatal mortality (stillbirth or death during the first seven days after birth). We used this combined outcome, in lieu of using early neonatal mortality, to eliminate the possibility that early neonatal deaths incorrectly classified as stillbirths would confound the results. Pre-specified secondary outcomes included stillbirth and early neonatal mortality rates, mortality rates stratified by sex, birth weight, birth location and birth attendant, and one and five minute Apgar scores and the use of bag/mask ventilation.

Generalized estimating equation (GEE) extensions of logistic regression models that adjust for correlation of outcomes within communities were used to determine differences in maternal and neonatal characteristics between the pre- and post-ENC data and between the NRP intervention and control data. Adjusted relative risks (RR) and 95% confidence intervals (CI) using GEE extensions of multivariate log-binomial models are reported for the post- versus the pre- comparison of the effect of training in ENC, in the comparison of the NRP intervention versus control (no NRP) groups, and in the comparison of post-NRP versus pre-ENC. The data were analyzed using SAS version 9.2 (Cary, NC). To examine the possibility that benefits of ENC training were time dependent, we analyzed perinatal mortality as a function of time, modeled continuously, using a robust piecewise Poisson GEE model that included two covariates, location of birth and birth attendant.

The study was conducted in 12 communities. Baseline data were collected from June of 2005 until November 2005 in all but two communities; in these communities, the study did not begin until July of 2006, and there was no period of baseline data collection. Therefore, only post-NRP data from these communities (one control and one intervention community) were used in analyses. During pre-ENC period, there were 1,867 births, and following ENC training but before NRP training, a period of approximately 13 months, there were 5,528 births (Figure 1 and Table 1). During the baseline pre-ENC period, nearly 80% of births were attended by TBAs, and a similar proportion occurred either in the home of the mother or of the TBA. Following ENC training, more births were attended by nurses or nurse midwives, and births more commonly occurred in clinics. The proportion of Apgar scores <4 at one and five minutes and the use of bag and mask ventilation remained the same after ENC training compared to during the baseline period.

Outcome data at 7-days were available for 99.8% of births. The stillbirth, early neonatal and perinatal mortality rates did not decrease among all births during the period from ENC training to NRP training compared to births during the baseline pre-ENC period (Table 2), nor did these rates decrease during this time in any pre-specified subgroup defined by birth attendant, site of delivery or birth weight category (data not shown). To eliminate the possibility of bias due to differential exclusion of cases based on an estimated (rather than measured) birth weight less than 1,500 g, we performed another analysis limited to births in which birth weight was measured; results were materially unchanged (data not shown)

Training in NRP occurred in January of 2007 in six communities, followed by a 12 to 15 month period of data collection in all 12 communities. There were no significant differences in rates of stillbirth, perinatal mortality and early neonatal mortality after the time of training in the NRP communities compared to the control communities (Table 2). There were no significant differences in mortality between communities in any of the subgroups defined by birth attendant, site of delivery or other variables.

We examined change in outcomes over the entire study period by comparing early neonatal and perinatal mortality rates in the pre-ENC cohort to rates in the cohort after NRP training. Because the mortality outcomes were not significantly different between control and intervention communities following NRP training, their data were combined in these analyses. There was a decline in perinatal mortality (50 to 40 per 1000 births; RR 0.8, 95% CI 0.66-0.97; Table 3) that was attributable to a decline in early neonatal mortality (27 to 17 per 1000 live births; RR 0.60, 95% CI 0.39-0.93; Table 4). The numbers-needed-to-treat for all birth attendants, that is the estimated numbers of infants that would need to be delivered following ENC training, to prevent one perinatal and one early neonatal death were 98 and 88, respectively. The declines in mortality occurred among births attended by all birth attendant types and both in homes and facilities, but the greatest reductions appeared to occur among deliveries attended by nurses or nurse midwives, and in clinics.

We explored the possibility that time following ENC training or other variables (for example, location of birth and birth attendant) might explain the reduction in perinatal mortality over the entire study period. We began by plotting mortality rates as a function of three-month increments of time (Figure 2). During the three months prior to ENC training, perinatal mortality appeared to increase because of increases in both stillbirths and neonatal mortality. At approximately three months after ENC training both perinatal and neonatal mortality appeared to decline. The piecewise Poisson model with a hinge at one year after ENC training showed that the coefficient for time since ENC training, after adjustment for birth attendant type and location of birth, was significant (P = 0.0235), and the relative risk of perinatal mortality for babies born one year after ENC training compared to those born at the start of ENC training was 0.73 (CI: 0.56-0.96). For the piece following the hinge point (one year after training) until the end of the study, there was not a significant correlation between time and mortality.