Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06175520 |
| Other study ID # |
PR-21032 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2021 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
December 2023 |
| Source |
International Centre for Diarrhoeal Disease Research, Bangladesh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this study is to test the feasibility and acceptability of introducing
preconception care into the public health system targeting newlywed couples in increasing the
uptake of maternal, neonatal health, and family planning services. The Investigators will
follow a cluster randomized controlled trial design to implement this study. Twenty-four of
the 30 clusters will be selected based on similar characteristics, then will be randomized
into intervention and control arms prior to enrollment of the study participants. Therefore,
there will be 12 clusters under each arm. Eligible participants from both arms will be
surveyed at baseline and 3, 6, 9, 12, 15, 18, 21- and 24-month follow-ups. So, all the newly
married couples both in intervention and comparison areas will be followed up prospectively
and periodically. The Investigators will introduce preconception care to the existing
government health system to ensure healthy pregnancy as well as to improve maternal, child,
and adolescent health. For this study, The Investigators propose a package of preconception
care interventions such as: screening for nutrition conditions, tobacco use, genetic
condition, environmental health, infertility/ sub-fertility, family planning counseling and
services, infectious diseases, and Vaccinations.
Description:
Bangladesh has one of the world's highest rates of child motherhood. Young motherhood is
associated with several risks such as: higher maternal mortality rates, pregnancy
complications, and low birth weight babies. A significant proportion of first-time mothers
are adolescents and this group of women has a high rate of morbidity and mortality. In
Bangladesh, maternity care does not start until the pregnancy is established. The number of
births to adolescent mothers has reduced by almost one quarter in the past 18 years but the
pace of decline is very slow and adolescent motherhood remains common in rural areas.
Preconception care provides an opportunity to optimize the health of potential mothers and to
prevent harmful exposures from affecting the developing fetus. In fact, preconception care is
the provision of biomedical, behavioral, and social health interventions to women and couples
before conception occurs, aimed at improving their health status, and reducing behaviors and
individual and environmental factors that could contribute to poor maternal and child health
outcomes.
The investigators propose to conduct this study in three Upazilas (Sub-districts) of
Gaibandha district in Bangladesh. The sub-districts are: Sundarganj, Palashbari, and
Sadullapur. The project will be implemented in collaboration with the Directorate General of
Health Services (DGHS) and Directorate General of Family Planning (DGFP).
At the community level, Family Welfare Assistant (FWA) will identify women who want to be
pregnant soon (in the next 3 to 6 months) and will send them to FWV at UH&FWC. Our initial
target is to identify and enroll newlywed women 6 months prior to pregnancy but at least 3
months will be ensured so that women can get ready to conceive after recovery from any health
complications through the preconception screening and treatment procedure. For some health
problems, such as infectious diseases like TB, it takes 6 to 9 months to complete the dozes.
FWA maintains a family planning registrar where information of all couples related to use of
contraceptives is available. Basically, FWA knows who are using or not using any
contraceptive methods, who are pregnant, who are planning for pregnancy and who need what
sort of FP methods. From that list they will find those couples and bring them to
preconception care from the community level. Apart from FWA, other community-based health
workers such as CHCP of Community Clinic and Health Assistant (HA) of DGHS department will
also be involved in recruiting the eligible couple under this intervention. Once newlywed
couples are identified, they will be referred to UH&FWC for preconception care. If any health
problems are diagnosed with those, they will go through proper treatment and newlywed women
will be made fit for pregnancy and the other groups may be allowed to go for safe pregnancy.
However, at the facility level, healthcare providers especially FWV will provide the
preconception care where our main target is to screen the women for some specific health
problems and provide necessary supplements. FWV will screen for health problems such as:
infectious diseases (e.g., TB), Hypertension, Anaemia, Diabetes Mellitus, Thyroid problems,
STI/RTI/UTI, Nutritional status (e.g., BMI), Thalassemia symptoms, Thyroid symptoms, sever
Dysmenorrhea, Obesity, Immunization status specially for TT & MR and even Covid-19, and
Symptoms of acute HBV infection, etc. Provider will also consider age, menstrual history and
reproductive history during preconception screening. Required test for screening these health
problems are available at the UH&FWC but for some specific test (like TB test, hemoglobin
electrophoresis test) which is not available at FWC, women will be referred to Upazila Health
Complex. If provider finds any abnormality from the screening test which is a risk for a
woman to become pregnant and for her newborn; woman will be provided proper counseling,
treatment, and referral to appropriate Gynae consultants or at facility.
The purpose of preconception care is to rid potential mothers of such health problems even
before conception so that she is a healthy individual while carrying her child, which would
result in a healthy, developed baby. Preconception care will fulfill this basic right to all
potential mothers and ensure the safety of the baby with the help and support of the
government health system. The investigators expect the outcome of the intervention is that it
will significantly decrease complications during pregnancy and childbirth, adolescent and
unintended pregnancies can be prevented to ensure delaying the first births, skilled
attendance at ANC, delivery and PNC will be increased, and postpartum family planning
practice will be increased to ensure spacing between births. The impact of the project is
expected to be healthy pregnancy and birth outcomes and reduced maternal and child morbidity
and mortality.
As mentioned, the current system of providing maternal health services starts with pregnancy
registration which leaves no opportunity to cure some health complications. Delayed detection
of pregnancy and registration with health service providers often cause delay or omit the
first ANC which cause different health complications for mother and the newborn. So, the
investigator's aim is to avert the health complications by bringing married adolescents to
preconception care and remove the risks and make women fit for healthy pregnancy for positive
birth outcomes.
Distribution of FP Gift box to the eligible couples: Newlywed couples who are under 20 years
of age will be primary target beneficiaries for the first level of intervention. At the onset
of intervention, the investigators will provide training to Marriage Registrars (Kazis) on
how to counsel newlywed couples and where to refer them for appropriate preconception
screening and care. Marriage registrars will be linked with health care providers so that
they can work in a team to maximize the outcomes. This will have the added benefit to the
midwives, FWVs, FWAs and Kazis establishing a linkage and a working relationship among them.
Delivery of FP Gift box by Marriage Registrar (Kazi), was piloted earlier elsewhere in
Bangladesh. In the study area, all the marriage registrars (Kazi) will be involved in this
intervention and trained under this study. On the occasions of marriage, marriage registrar
will hand over a gift box. Marriage Registrar or Kazi will be sensitized about the importance
of family planning specially to delay the first birth of newly married adolescent girls and
spacing between births. After the sensitization, a FP gift box will be provided to newlywed
couple by Kazi at the time of marriage registration wherever it occurs at Kazi office or at
bride's residence homes. FP Gift box contains a comprehensive handbook consist of several
information related to husband-wife relationship, relationship with in-laws, food and
nutrition, pregnancy plan, access to FP information and services, pregnancy and child care
including vaccinations. It covers complete information for continuum of care. Besides, a few
Condoms and Pills will be there in the gift box to provide them to newlywed couple so that
they can meet their immediate demand just after marriage until they come to contact with
family planning worker.
Couple counseling and family engagements: During preconception care and distribution of FP
gift FWA, FWV, and MR will arrange couple counselling to involve male partners in the
intervention. A training manual will be developed to be used by the health workers and MR for
the event of couple counseling. The manual will include the information regarding importance
of preconception care, the use of family planning methods, delayed childbearing, spacing
between births, skilled care during pregnancy, at child birth, and postnatal period. Besides,
the investigators will also incorporate some other important messages related to a healthy
lifestyle such: not taking tobacco, not smoking and avoiding passive smoking, husband-wife
respectful relationship, consequences of physical and mental violence to pregnant women,
foetus, and postpartum women, dental care, physical exercise, healthy diet, etc to ensure
healthy pregnancy.
As per the Bangladeshi community context, family members such as husbands, mother-in-law,
father-in-law, mother and fathers somehow help and influence young married women in making
decision to seek pregnancy-related care. Our intervention will cover the male partners
(husbands) in the couple counselling event and other family members especially mother-in-law
or mother will be engaged through organizing community events by the health workers. The
event like 'Bou-Sasurir Mela' (bride and mother-in-law gathering) will be organized to aware
them about the importance of pre-conception care, use of modern family planning methods,
delaying adolescent pregnancy and spacing between births.
Digital health intervention using eMIS platform: At the community level, FWA does the
eligible couple (ELCO) registration, pregnancy registration, collect information about FP
used by the couples, provide FP messages and short-term methods; refer to UH&FWC for LAPM and
pregnancy care. The proposed study will take this as an opportunity to use this eMIS
platform. The FWA eRegister is an electronic version of the existing paper register. Once an
eligible couple is registered, they will be provided with necessary SBCC information related
to preconception care as per the design of the program. Targeted client-specific SBCC
messages will be developed for the newlywed couples to provide them with family planning and
preconception care-related messages.
The adolescent girls women with primi-gravida (first-time young mothers) who are less than 22
years of age in selected Upazillas will be the primary beneficiaries of the second-line
intervention. The MCH handbook is one of the tools that have been considered globally to
improve access to quality health care by pregnant women including family planning services,
ANC, delivery and post-partum services. This is basically an extended version of ANC card
that contains information related to ANC, five danger signs, PNC, newborn danger signs, etc.
Once a pregnant woman registered by an FWA, she will be provided with MCH Handbook. There is
contact number of local midwives in the MCH handbook. Pregnant women will contact to midwife
for ANC and follow-up ANC check-ups. MCH hand book keep the track of every information
related to ANC, delivery and PNC. Overall, the aim of providing the MCH handbook is to
establish a referral linkage between community-based health workers and facility-based
healthcare providers to increase the skilled care at antenatal, delivery and postnatal
periods including the facility delivery.
Before the intervention, a baseline data collection will be conducted in both the
intervention and comparison areas. During the intervention, a regular follow-up will be
carried out to collect monitoring data. After the intervention, an end-line data collection
will be done to determine the effectiveness of the intervention. However, at baseline and end
line, both quantitative and qualitative data collection will be carried out in the
intervention, and control Investigators will apply mixed-method approaches to collect data.
For performing quantitative analysis, The Investigators use the statistical software package
SPSS STATA, or R based on suitability. To analyze the qualitative data of this study, The
Investigators will apply the 'Framework Approach'.
