MODELO DEL METABOLISMO DEL CALCIO Y FÓSFORO PARA LA

Primary, secondary and process outcome measures for the RCT are described in this section and summarized in Table 11.

Table 11: RCT outcome measures STUDY OUTCOMES

Primary outcomes _{a. Attendance at scheduled postnatal care (at least 2 consultations)} b. Exclusive breastfeeding at 3 months postpartum

c. Use of effective modern contraception at 8 months postpartum Secondary outcomes _{a. Use of long acting or permanent (LA/PM) methods of}

contraception at 8 months postpartum

b. (1) Any contraceptive use at 3 months postpartum (2) Any contraceptive use at 8 months postpartum c. Timely initiation of effective modern contraception d. Unmet need for contraception at 8 months postpartum e. High relationship adjustment at 8 months postpartum f. Complete satisfaction with routine care

Process outcomes _{a. High adherence to the intervention}

Primary outcomes:

a. Attendance at scheduled postnatal care (at least 2 consultations)

Based on the minimum number of outpatient postnatal check-ups recommended by the national protocol (Ministère de la Santé, 2010a), a woman was classed as having attended scheduled postnatal care if she had attended at least two consultations in the first six weeks after birth. These usually include one consultation at six days and one at six weeks (42 days) postpartum (see Subchapter 1.3.4).

Data for this outcome were collected through 3-month postpartum follow-up interviews, supplemented by health facility records in cases of loss to follow-up.

b. Exclusive breastfeeding at 3 months postpartum

Although exclusive breastfeeding is recommended for the first 6 months postpartum, 3 months was chosen as the reference period because by that point only 25% of infants are still

exclusively breastfed in Burkina Faso (see Subchapter 1.3.4) (INSD, 2012). We estimated that an increase in the duration of EBF to this time point would provide a meaningful and achievable public health gain in this context. Data were therefore collected during the 3-month follow-up interview, for infants who were alive at that time.

The definition of exclusive breastfeeding was based on the WHO criteria: “the infant has received only breastmilk from his/her mother or a wet nurse, or expressed breastmilk, and no other liquids or solids with the exception of drops or syrups consisting of vitamins, mineral

89 supplements or medicines” (World Health Organization, 1991). During the interview, the mother was asked whether the baby had ever had one of a list of food/drink items, apart from breast milk. These included other milk, water, herbal infusions, juice, and others. Items were read out and discussed one at a time (see interview). If any additional item had ever been given to the baby, the interviewer enquired about the frequency with which the baby was having it. Breastfeeding was considered to be exclusive if the infant had never had any other food/drink item other than breast milk, or had had another type of food/drink only once or twice.

c. Use of effective modern contraception at 8 months postpartum

Effective modern methods were defined as those having a rate of unintended pregnancy per 100 women of 10% or less per year, as commonly used (World Health Organization and Center for Communication Programs, 2011). Based on local availability, these methods are: implants, IUDs, injectables, oral contraceptives, and permanent methods.

For this outcome and for secondary outcomes related to contraception, each woman was considered a “user” or “non-user” for each method. She was considered a user of the implant if she had an implant in place at the time of interview; of the IUD if she had an IUD sited; of injectables if she had received an injection in the three months prior to the interview; of oral contraception if she took a pill within the 24 hours prior to the interview or according to instructions; of permanent methods if she or her husband had undergone sterilization or vasectomy. This outcome was calculated as a proportion out of all women followed up. Based on the national protocol, progestin-only pills are the only oral contraceptive provided in the first 6 months postpartum (Ministère de la Santé, 2010b).

Data for this outcome, as well as for contraception-related secondary outcomes, were collected through the 8-month postpartum follow-up interviews.

Secondary outcomes:

a. Use of long acting or permanent (LA/PM) methods of contraception at 8 months postpartum

This was defined as the proportion of women (out of all women followed up) using IUDs, implants, female sterilization or male sterilization at 8 months postpartum.

b. Any contraceptive use at 3 and 8 months postpartum

This was defined as the use of all contraceptive methods, according to self-report, at 3 and 8 months postpartum (calculated among all women followed up in each round). This broader definition of contraception was included in order to account for the use of “natural” methods, such as withdrawal, which may be higher than reported in DHS surveys (Rossier et al., 2014). Traditional methods were also included. Data from both follow-up rounds were used.

90 c. Timely initiation of effective modern contraception

For postpartum women, the likelihood of conception increases over time since the index birth. Timeliness of initiation of effective modern contraception was defined as the initiation having taken place within a specific timeframe during which a repeat conception was reasonably unlikely. The criteria used to establish whether contraception initiation was timely or not, as a dichotomous variable, and are spelled out in Table 12. They are based on the duration and conditions during which lactational amenorrhea provides 98% protection against unwanted pregnancy, which are also the principles that characterise women as intentional or default LAM users (Labbok et al., 1997).

If the woman initiated contraception within 6 months AND had been exclusively breastfeeding at 3 months, the initiation was considered to have been timely as long as she had not previously resumed intercourse in the presence of menses. This is because lactational amenorrhea, while it lasted, provided reasonable protection until the time she started the method. However, if a woman had initiated the method later than 6 months postpartum, OR if she initiated it earlier but had not been exclusively breastfeeding, initiation of contraception had to precede the

resumption of intercourse in order for it to be considered timely, regardless of the presence of menses. This is because the likelihood of ovulating prior to the return of menses is higher after 6 months or in the absence of exclusive breastfeeding.

This outcome was assessed with users of effective modern contraception at 8 months as the denominator. Data were drawn from the 3- and 8-month postpartum interviews.

Table 12: Timeliness of initiation of contraception At the time of initiation:

Initiation within 6 months PP AND EBF at 3 months

Initiation after 6 months PP OR not EBF at 3 months

Timely Not timely Timely Not timely

Amenorrhea + abstinence X X

Amenorrhea + sexually active X X

Menses returned + abstinence X X

Menses returned + sexually active

X X

d. Unmet need for contraception at 8 months postpartum

Several definitions of unmet need for contraception have been proposed. The Revised definition of unmet need published by the DHS Program in 2012 was chosen (Bradley et al., 2012).

In accordance with this definition, women who were in union at 8 months postpartum and who were not using a contraceptive method were divided into two groups. In the first group were women whose menses had returned, and in the other were women who were still postpartum amenorrheic or were pregnant again. Women whose menses had returned (first group) were classified in the following way:

91 - Women who wanted no more children = need for limiting

- Women who wanted a child in two or more years, who wanted a child and were undecided about timing, or who were undecided about having another child = need for spacing

- If the data on the wantedness of future children were missing, need status was classed as missing.

Women who were still postpartum amenorrheic or were pregnant again (second group) were classified in the following way:

- Women who wanted the last birth or the current pregnancy at that time = no need for contraception

- Women who did not want the last birth or the current pregnancy at all = need for limiting

- Women who wanted the last birth or current pregnancy later = need for spacing - If the data on the wantedness of the last birth or current pregnancy were missing, need

status was classed as missing.

Women in either group who had a need for contraception (spacing or limiting) were classified as having an unmet need if they were not using a family planning method at 8 months

postpartum.

Data were drawn from the 8-month postpartum interviews. In addition, for amenorrheic, non- pregnant women, baseline data on the wantedness of the last birth were used. For women pregnant at 8 months, data on the wantedness of the current pregnancy were extracted from the fertility intentions expressed during the 3-month follow-up.

e. High relationship adjustment at 8 months postpartum

Relationship adjustment was defined as the woman’s satisfaction with the relationship and the degree of communication, shared decision-making and agreement within the couple on key issues related to reproductive health. Data were drawn from the 8-month postpartum interviews and based on women’s self-report. I developed a tool for measuring this outcome by adapting existing questionnaires, including Spanier’s Dyadic Adjustment Scale and the Locke-Wallace Marital Adjustment Test (LWMAT) (Spanier, 1976, Locke and Wallace, 1959). Questions from these instruments that were not relevant to the context were modified or eliminated, and others were added to capture agreement and shared decision-making relative to reproductive health and care-seeking.

The final tool contained 18 questions, concerning: - overall relationship satisfaction,

- the frequency of communication within the couple on the following issues: the number of children to have in the future, health care seeking for children, how children should be fed, contraception, and the amount of time to wait before having another baby, - the level of agreement on those same issues,

92 - who in the household makes decisions on the following issues: infant feeding, routine

and emergency health care for children and for the woman herself, the use of contraception, and when to resume sex after birth.

The response to each question was assigned a score of 0 to 3 points. The highest the levels of relationship satisfaction, communication and agreement on key issues, and the ability to refuse sex, the more points were scored. For the questions on decision-making, the most points were scored when the couple decided together on an issue, and the lowest points were scored when the woman was not involved in the decision. Because we also aimed to capture the level of interest that the man took in the health of his family, the score was intermediate if the woman decided alone. The total score was calculated for each woman by summing the number of points scored for each question. Though it would have been possible to analyse this outcome as a continuous variable, I decided to recode it as a binary variable for simplicity and to make it easier to compare the effect with that of the other outcome indicators. The median score of 16 was chosen as a cut-off point for the constitution of a high-adjustment group and a low- adjustment group.

g. Complete satisfaction with routine care

Data on satisfaction with care were collected during the 3-month follow-up interview. The aim of measuring satisfaction was to check that women’s experience of routine care throughout the period of pregnancy, birth and postpartum did not differ between the two study arms. The questions did not specifically refer to the care received as part of the intervention sessions, in order to ensure comparability between the two arms.

A measurement tool for satisfaction was developed by adapting questions from the K4 Health’s Respectful Maternity Care toolkit, and from the UK’s Care Quality Commission (CQC)’s 2013 Maternity Services Survey (USAID & MCHIP, 2013, Care Quality Commission (CQC), 2013).

The tool comprised 8 questions, which covered the following issues: - the clarity of language used by staff,

- the opportunity to ask questions,

- the receipt of satisfactory response to questions asked,

- staff’s respect for personal wishes or preferences in relation to care or treatment options, - staff’s respect of intimacy/privacy,

- the correct treatment of confidential personal information, - experiences of impatient or angry behaviour on the part of staff,

- staff’s respect for the woman’s wish to have, or not to have, a companion present. Each question contributed either zero or one point, so that the maximum score was 8. Though it would have been possible to analyse this outcome as a continuous variable, I decided to recode it as a binary variable for simplicity and to make it easier to compare the effect with that of the

93 other outcome indicators. A score of 8 was interpreted as complete satisfaction with care, and any score below that corresponded to less than complete satisfaction (dichotomous outcome).

Process outcomes:

a. High adherence to the intervention

Participation in each component of the intervention was recorded (A, B & C), and the woman/couple were considered highly protocol-adherent if they attended at least two

intervention components. Data on the participation to each session were collected from study documentation forms, compiled by health workers throughout the implementation period (see Subchapter 5.3.8).