TITLE:

COMPARISON OF IMMEDIATE POSTPARTUM AND INTERVAL INSERTIONS OF LONG-ACTING REVERSIBLE CONTRACEPTIVE METHODS IN JUTH, JOS

DR VICTOR CHUNG PAM

DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY,

UNIVERSITY OF JOS, JOS NIGERIA

2016

Abstract

Background: For many Nigerian women, childbearing starts at an early age with short inter-birth intervals resulting in a very high lifetime total fertility rate^. This resulting fertility pattern is what contributes to the excess maternal and neonatal morbidity and mortality. Effective contraception, especially the long-acting reversible contraceptives (LARC) have the potentials to reduce maternal deaths by 30% and neonatal deaths by 10%. Yet Nigeria has a contraceptive prevalence of 15% with less than 10% using a modern method. Most of the modern method in use is dominated by the short-acting methods such as pills, injectables and condoms with less than 1% of women using any of the LARC methods.

The WHO advocates postpartum contraceptives as a primary strategy for reducing unintended pregnancies and optimizing birth spacing in the first 12 - 18 months after delivery. Failure to successfully initiate postpartum contraception can easily result to a rapid repeat pregnancy – defined as a pregnancy within 12-18 months after delivery. This is because the total prospective unmet need for spacing and limiting births in the first year after delivery is 60 – 80% in many developing countries. Moreover, unplanned pregnancies increase the risk for morbidity and mortality. They also result in poorer health-related outcomes than pregnancies which were wanted: delayed commencement of antenatal care, low birth weight and preterm delivery. An unintended or mistimed pregnancy can also make a woman to suffer economic hardship and make her fail to reach her educational and career goals. There is therefore a huge potential to integrate postpartum contraception into the maternal ecosystem to ensure that women who have a facility birth leave with their chosen contraceptive method without waiting for the postnatal visits[ZA1] .

Aims: The overall aim of this research is to determine the rate of uptake of immediate postpartum insertion of LARC methods before women who have a facility birth are discharged compared to the uptake of the same methods at least 6 weeks (interval) after delivery

Methodology: This is a prospective cohort study[ZA2]  of a sample of women at the antenatal clinic of the Jos University Teaching Hospital (JUTH) who consent to having a LARC method after delivery. A sample size of 160 subjects was determined using an effect size of 20% higher uptake of immediate postpartum LARC over interval insertion at a significance level of 0.05[ZA3] %, a power of 80% and an estimated attrition of 10%. The outcome measures are the number of LARC methods accepted and the mean continuation rates in each cohort. All data will be analyzed using Stata 12.1. Ethical clearance will be obtained from JUTH Human Research Ethics Committee.

Background and Significance

For many Nigerian women, childbearing starts at an early age with short inter-birth intervals resulting in a very high lifetime total fertility rate^1. This resulting fertility pattern is what contributes to the excess maternal and neonatal morbidity and mortality.¹ Effective contraception, especially the LARC methods have the potentials to reduce maternal deaths by one-third and childhood deaths by one-tenth since the risk of child mortality is highest for shorter than recommended birth-to-pregnancy intervals^2-5.

The contraceptive prevalence rate in Nigeria according to the Nigeria Demographic Heath Survey 2013 is 15% with only 10% of married and/or single but sexually active women relying on a modern method⁶. Disturbingly, amongst the meager 10% modern contraceptive methods use, Nigerian women rely more on the less efficacious short-acting injectables (3%), male condoms (2%) and the pill (2%)⁶. The most efficacious contraceptive methods such as IUCDs and implants are used by 1% of women or less². Access to these IUCDs and implants could help women who have completed their family size without reaching a decision for a permanent method to deal with ambivalence and difficulty with adherence to shorter-acting or coital-dependent methods. This is because once the LARC methods are inserted; they cannot be stopped by doing nothing leading to their long continuation rates².

The prevalence of postpartum contraceptive use is highest where contraceptive counseling is provided during both the antenatal and postnatal time periods⁷. The WHO strongly advocates postpartum contraceptives as a primary strategy of reducing unintended pregnancies and optimizing birth spacing in the first 12 - 18 months after delivery^{3, 7}. Failure to successfully initiate postpartum contraception can easily result to a rapid repeat pregnancy – defined as a pregnancy within 12-18 months after delivery⁸. This is because the total prospective unmet need for spacing and limiting births in the first year after delivery is 60 – 80% in many developing countries³. Moreover, unplanned pregnancies increase the risk for morbidity and mortality⁹. They also result in poorer health-related outcomes than pregnancies which were wanted: delayed commencement of antenatal care, low birth weight, preterm delivery, lesser proportion of women delivery under medical supervision, maternal substance use, poor immunization and stunted growth of the children^{7, 10}. An unintended or mistimed pregnancy can also make a woman to suffer economic hardship and make her fail to reach her educational and career goals¹¹.

The recent pronouncements of the safety of immediate postpartum LARC by different clinical guidelines have created opportunities to increase the uptake of these contraceptive methods in the maternal ecosystem¹². The immediate postpartum period is the most ideal time to initiate a method: women are most motivated with the least ambivalence about starting a method, the in-patient is convenient for the woman and provider, no lingering doubt about the women being pregnant because of amenorrhoea and the women are discharged with their chosen methods^{7, 12}. This ensures protection before they resume any sexual activity (median 2.8 months in Nigeria) or return to fecundity which may occur well before the resumption of menstruation especially in non-breastfeeding women^{1, 6.} Besides, it has been shown that few women who have a facility birth return for further postnatal care^{13, 14}. In Nigeria, this failure to return for the 6-week visit may be partly due to failure to secure permission from the husbands to return to the facility. This barrier can therefore be circumvented by the immediate postpartum placement of the LARC method. Furthermore, because husbands who are gatekeepers for contraceptive decision-making hardly attend the prenatal care with their wives, the time of labour, delivery and the immediate postpartum period present an opportune and auspicious time to target them for contraceptive counseling so as to dispel any myths and clarify any misconceptions leading to the removal of any barriers to contraception by their wives or themselves. The aim of this study is to determine the rate of uptake of LARC methods in the immediate postpartum period and compare with the uptake of these methods in the interval period.

Preliminary Data

Previous studies from the family planning unit of JUTH have demonstrated a high percentage of lost to follow up^{15, 16}. This is partly the result of the absence of a mechanism for tracking the women and reminding them about their follow up visits. This affects the quality of data collected and perhaps introduces some selection bias during analysis. Provision of immediate postpartum contraceptive to desiring women is currently limited to just bilateral tubal ligations done at planned caesarean sections. No contraceptive implant (Jadelle or Implanon) had ever been inserted in the postpartum period before discharge in JUTH¹⁷.

AIMS AND OBJECTIVES

The overall aim of this research is to determine the rate of uptake of immediate postpartum insertion of long-acting reversible contraceptive (LARC) methods before women who have a facility birth are discharged compared to uptake of the same methods at least 6 weeks (interval) after delivery.

The primary research question is, ‘’Does the provision of LARC methods in the immediate postpartum period result in a significantly greater rate of uptake of the methods compare with the interval uptake  of these LARC methods?” Our first secondary hypothesis is that insertion of LARC methods in the immediate postpartum period would result in longer periods of continuous use of the methods compared with those inserted at interval. The second secondary hypothesis is that women using a LARC method (both immediate postpartum and interval) who receive mobile-phone text messaging reminders are more likely to adhere to their follow up visits to the family planning clinic compare to those who do not receive any text messaging reminders.

Specific Aims

• To determine the difference between number of women in JUTH who accept a LARC method in the immediate postpartum period and those who accept the method at least 6 weeks postpartum (interval) over a one-year period.
• To determine the difference if any, between the average period of use (in months) of LARC methods inserted in the immediate postpartum period and those inserted at interval.
• To determine the differential impact of mobile-phone text messaging reminders on follow-up adherence between women using a LARC method in JUTH who receive text reminders over a one-year period and a control group that do not receive such reminders.

Experimental Design and Methods

Design: This is a prospective cohort study[ZA4]  of a sample of women at the antenatal clinic in JUTH.

Setting

JUTH is a 500-bed teaching hospital. Its Obstetrics/Gynaecology unit consists of a Delivery ward which conducts about 4,000 deliveries per annum. The antenatal clinic caters for about 200 women each day Monday to Friday and its services include a one-hour health talk on myriad issues including family planning group counseling, nutrition in pregnancy, cervical cancer screening information, breast examination, children’s immunization schedule, tetanus immunization and maternal hygiene.

The family planning unit consists of 6 nurses/midwives who are trained counselors and have the requisite experience to provide all types of family planning methods. Two resident doctors are posted to the family planning unit each month. Together with the two Consultant Obstetricians/ Gynaecologists who supervise them, these residents carry out bilateral tubal ligations for women who are desirous of a permanent method. Each year, the family planning unit provides on an average about 1, 200 LARC methods inserted on an interval basis (550 IUCDs, 400 Implanon implants and 250 Jadelle implants) to consenting women. All family planning methods are provided free of any charges by the Federal Government of Nigeria.

Study Population

The study subjects shall be recruited from pregnant women attending the antenatal clinic during the study period.

Inclusion criteria: all women at the antenatal clinic who consent to having a LARC method after delivery.

Exclusion criteria: women who have contraindications for the use of IUCDs, Jadelle or Implanon. Also, women who have their antenatal care outside JUTH but receive their LARC method from the facility. No woman shall be excluded on the basis of her age, parity, ethnic group, race, religion or other affiliations.

Demand Creation for LARC Methods

Family planning group counseling is one of the activities covered on each antenatal clinic day. In addition to this, the study will carry out demand-creating activities like printing of pamphlets and posters on the LARC methods explaining their modes of action, side effects, insertion and removal procedures, duration of use and advantages. There will be a section on frequently asked questions on LARC methods. The introduction and provision of these methods in the immediate postpartum period in addition to the already available interval method would be highlighted. The pamphlets would be given to the pregnant women to carry home to share with their husbands. The telephone number of the family planning clinic would be provided to help answer any questions during working hours from Mondays to Fridays during the study period. Posters will be displayed in strategic locations in the hospital to increase awareness about the availability of immediate postpartum LARC methods in addition to the interval insertions.

Individual counseling will be offered to every woman who is considering accepting a method by the Nurse counselors. A specially designed sticker will be placed on the antenatal records of every consenting woman indicating her tentative chosen method. This is to help all skilled birth attendants in the labour ward to call the attention of the research team whenever such women present in labour.

Sample Size

Using Stata version 12.1, a sample size of 160 subjects (80 in each cohort: immediate postpartum versus interval) was calculated using a hypothesized expected difference (effect size) of 20% higher uptake of the immediate postpartum LARC over the interval insertions, a level of significance α of 0.05%, a power of 80% and an estimated attrition rate of 10%.

Data Collection and Management

Ten resident doctors and 15 nurses/ midwives in the labour and postnatal wards would be trained on the insertion and removal procedures of these LARC methods. The training will also emphasize counseling skills and data collection strategy. This will ensure that a robust research team for the study is built and developed.

At the insertion of a chosen method in the labour ward or the postnatal ward, each study subject will be given a unique identification number.  Baseline demographics, reproductive history, type of method received, date of insertion, telephone numbers, alternative telephone numbers (eg husband’s telephone), blood pressure, weight, height and body mass index (BMI) of subjects will be collected on standard case report forms. During subsequent follow up visits, data on date of visit, blood pressure, weight, Body Mass Index (BMI) and presence of any side effects will be recorded on the same standard case report form for each subject. At any visit where a method is discontinued by any subject, the date and reasons for the discontinuation of the method are noted. If a method is expelled (for IUCDs only) or the woman becomes pregnant while using the method, the date of the visit when the expulsion or failure of method is confirmed is noted.

At both the recruitment and follow up visits, the research team will review the data to ensure its adequacy and completeness. All the data collected will be entered into a secure computerized database designed sorely for the purpose of data collection and analysis. Only unique subject identifiers will be used. Weekly quality assurance checks of the database will be performed to ensure data accuracy.

Randomization of women into text message receiving group and control

All women who received any family planning method are usually given a small Hand Card where the dates of subsequent follow up appointments are written. They are seen every three months at the clinic. In this study, the 80 subjects in each cohort (whether Immediate postpartum or interval insertion) will be randomly divided equally into an intervention group and a control group using a computer-generated table of random numbers. Women in each cohort that are randomly assigned to the intervention group will receive, in addition to the hand card appointments, 3-monthly mobile-phone text messaging reminders for their follow up visits. Women in the control group will only have the Hand Card appointments.

Analytical Plan

The baseline characteristics of study subjects will be described using proportions, median, inter-quartile range, mean, standard deviation, frequency and percentage. For comparisons between immediate postpartum and interval insertions, the student’s t test will be used for continuous variables and chi square for categorical data. Kaplan-Meier methods will be used to calculate the cumulative continuation rates of use of LARC methods between the immediate postpartum and interval insertions. Kaplan-Meier curves will also be graphically employed to depict the continuation over time. To identify the demographic and behavioural predictors independently associated with discontinuation of LARC methods after the immediate postpartum or interval insertions, univariate and multivariate analyses will be performed using Cox regression analyses. The criterion for significance for all analyses will be set at a P-value of α = 0.05. All statistical analyses will be done with the statistical software package Stata, version 12.1 (College Station, Texas USA).

EXPECTED OUTCOMES

This is a study on the uptake long-acting reversible contraceptives which explores the different rate of uptake of the methods in the immediate postpartum period after delivery before the women are discharged and compare with the uptake of the same methods at least 6 weeks after delivery. The results of this study will provide us with better insight and understanding on how to improve our family planning services in JUTH. It will enable us to improve the uptake of these highly efficacious contraceptive methods that are highly under-utilized.

The primary outcome measures of interest are (i) number of LARC methods accepted in the immediate postpartum period and at interval (ii) mean continuation period of use (in months) of LARC methods inserted in the immediate postpartum period and at interval (iii) percentage of women in the intervention and control groups who have 100% adherence to their follow up visits. Other secondary outcomes will include a comparison of number and type of side effects, reasons for removal of LARC methods, expulsion rates of IUCDs and failure rates between immediate postpartum and interval insertions.

Plan for Protection of Human Subjects

Risks/benefits to participants

This research will be done at minimal risk to the patients. There is a slightly higher risk of IUCD expulsion after postpartum insertion compare with the interval insertion. This will be clearly explained to the patients. Insertion of implants involves a minor surgery with minor discomfort/ pain. Like all contraceptive methods, there is also the risk of failure with LARC and should this occur patients would have to accept the unplanned pregnancy since we do not provide services for the termination of pregnancies.

The benefits to the patients however are enormous. Patients will receive free of any costs the most effective reversible methods of contraception after delivery with failure rates comparable to permanent methods like bilateral tubal ligation at less than 1 unintended pregnancy per 1000 users within the first year of typical use¹.   These ‘’forgettable’’contraceptive methods require no further action on a regular basis to ensure their effective action. These contraceptive methods also have to be removed by health workers rather than by simply stopping method which leads to their high continuation rates and pregnancy prevention¹. Most importantly, some of the patients will receive these highly effective methods as part of the continuum of care after delivery before discharge. This will cut down on the opportunity cost lost with the interval insertions.

Method of collecting informed consent

Patients would be counseled repeatedly during the antenatal clinic visits about the availability of immediate postpartum contraceptives in addition to the interval insertions. Leaflets and fliers on postpartum contraception would also be developed and given to these women to share with their partners at home.

They would also be educated about their rights to be treated with respect, including respect for their decision whether or not they want to be part of the study. Specifically they will be told that their choice of not being in the study will not result in any penalty or loss to any benefit to which they are entitled including their right to seek routine medical care at the centre or choosing any family planning method at a later date.

To be eligible for their chosen LARC method, patients would then be required to sign an informed consent form which will be kept in the antenatal records. Their rights to revoke the consent at any time including just before the insertion of the chosen method would be emphasized.  The patients will be instructed for the schedule of the follow up visits to the family planning clinic. They would be told about their rights for the removal of their chosen method at any time. This will be carried out at the family planning clinic.

Plans to safeguard the patient’s information

Patients would be assured of the confidentiality of their personal information. However, they would be made aware that participating in this study implies that they have given permission for their personal information and reproductive histories to be included in the study results which may be used for teaching, publications or presentation at scientific meetings. All such use will however not include any identifiers that will uncover their identity.

IRB Approval:

Ethical clearance for the study will be obtained from the JUTH Research Ethics Committee.

Budget: The table below shows the proposed budget to carry out the study