We performed a secondary analysis of the Yam Daabo study, which was a two-group, multi-intervention, single-blinded, cluster-randomized controlled trial with health centres as the randomization units. It was a study that involved two countries: Burkina Faso and the Demographic Republic of Congo (DRC). Health centres in each country were randomized into two groups: intervention and control. The intervention group's health centres offered a set of six postpartum family planning (PPFP) interventions that were identified as solutions to the barriers identified during the planning phase of the project [3]. The control group health centres provided the usual care PPFP. The study had the statistical power to detect a 15-point difference between the intervention and control groups in terms of the proportion of women adopting an effective PPFP method at 6-month. In each country, 8 health centres were selected (4 intervention and 4 controls) for the study, and, taking into account the loss to follow-up, each centre had to include 70 women (refer to the published protocol [2]).
The project interventions can be categorized into two broad groups: the supply-side interventions were the improvement of the availability of the PPFP services seven days a week and training/updating the clinical skills of health providers on the PPFP, including capacity building support supervision for service providers; and the demand-side interventions such as the PPFP counselling tool (new intervention tool taking into account all of WHO's new recommendations for offering FP services), appointment cards for women, and invitation letters for partners [3]. We included a total of 1,147 women in both countries, and 1,120 women had follow-up data.
The trial was approved by the WHO Research Ethics Review Committee, the ethics committee for health research in Burkina Faso and the School of Public Health ethics committee in DR Congo. Moreover, the trial was registered in the Pan African Clinical Trials Registry (PACTR201609001784334).
For the analysis of switching of the different methods, we adopted the classification of Trussels et al., which considered the switching between four groups (from the less effective to the more effective) [17] which are :
- First group: spermicide (correct use: at every sex), abstain, collier, other methods
- Second group: condoms, diaphragm, sponge, withdrawal (correct use: at every sex)
- Third group: Injections (repeat injections on time), Lactational Amenorrhea Method (LAM) until six months, Pills, patch, ring
- Fourth group: vasectomy (with the use of another method for the first three months), implant, IUD and female sterilization
We had no data on adherence to the method, hence we assumed that women used them correctly (especially for pills and injectables).
Discontinuation is defined as starting modern contraceptive use within 12 months postpartum and then stopping for any reason while still at risk of unintended pregnancy. If the woman stops using the second after switching the first one, the duration of use is that of the second method.
An episode of switching occurred when a woman, using a given contraceptive method, change for any reason to another contraceptive method. We excluded the women who stopped the first method because we were not able to classify them according to the chosen classification. So, for discontinuation and switching analysis, we only considered those who used pills or IUDs or injectables or implants at least once during the follow-up. The condom was not considered because it was used in combination with other methods (17 women). LAM was also not considered because it is ineffective after 6 months postpartum and therefore, necessarily leads to another more effective method.
We chose the discontinuation (for modern contraceptive methods) and the switching (for any method) as outcome measures. To compute the durations of the two outcomes, we listed different situations:
- Women started by using a method not classified in this analysis (abstain, collier, condoms, diaphragm, sponge, withdrawal, LAM until six months and other methods) and haven't used another one. These women were ignored in the statistical analysis.
- Women started by using a method not classified in this analysis and switched to pills, injectables, implants or IUDs. The duration of use was the time between second the method initiation and the end of the study (or the date of the last follow-up if the woman was lost-to-follow-up).
- Women started by using pills, injectables, implants or IUDs and switched to pills, injectables, implants or IUDs and then stopped the second method. The duration of use was the duration of the use of the second method.
- Women started contraception with pills, injectables, implants or IUDs and switched to a method not classified in this analysis (abstain, collier, condoms, diaphragm, sponge, withdrawal, LAM until six months and other methods) and then stopped the second method. The duration of use was the duration of the use of the first method.
We used survival analysis to estimate the effect of postpartum interventions on contraceptive discontinuation and switching. This technique allowed to include censored episodes in the estimation procedures. In this study, we defined an episode as a period of uninterrupted use of a contraceptive method that may or may not has ended. If the episode ended without switching to another method, then it was a discontinuation. One woman may report several episodes of contraceptive use. If another method was used after the first episode, then it was switching. The woman was right-censored if she started a method and did not stop it for the rest of the follow-up. She was left-censored if she started a method other than those excluded in the operational definitions given above.
The statistical significance and the effect of postpartum interventions of each outcome of interest were assessed using multivariate Cox regression modelling. We performed maximum likelihood estimation for parametric regression survival-time models. 95% CI and P value less or equal to 0.05 were set to determine the level of statistical significance.
After comparing the different models using the Akaike's Information Criteria (AIC), the best model was the Weibull survival distribution model (streg Stata's command) and therefore was selected to estimate the effect of the interventions on contraceptive discontinuation or switching. We opted for a hazard ratio (HR) estimate for our exposure variable and for the covariables.
A bivariate analysis with cluster effect correction was conducted initially to measure the possible association between interventions and the discontinuation or switching of the contraceptive methods, with primary health centres as clusters. Then, we adjusted the estimates by introducing into the model the type of method used. We analyzed each country separately and pooled data of both countries because they are different settings (urban in the DRC, primarily rural in Burkina Faso).
For switching, we use a multinomial logit model to estimate the effect of interventions on switching to a less or equal effectiveness method or to a more effective method. The reference group was that of the women who did not switch the first method.
We also reported the reasons of switching by method type on the one hand and also by the interventions group on the other hand.