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临床试验/NCT06175520
NCT06175520进行中(未招募)不适用

Introduction of Preconception Care Through the Public Health System to Improve Maternal Health and Family Planning Service Utilizations Among Young Women in Rural Bangladesh: A Cluster Randomized Controlled Trial

International Centre for Diarrhoeal Disease Research, Bangladesh1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2021年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,500
试验地点
1
主要终点
Through baseline and end line questionnaire survey the study will assess the proportion of recently delivered women utilized skilled ANC, DC, and PNC services

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
15 Years 至 20 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Newlywed couples who are under 20 years of age

排除标准

  • 未提供

研究组 & 干预措施

Comparison area

No Intervention

There will be 12 clusters under the comparison arm. Eligible participants will receive services through the existing health system.

Preconception care (PCC) intervention

Experimental

There will be 12 clusters under the PCC intervention arm. Eligible participants (newlywed women) in PCC intervention areas will be followed up prospectively. The investigators will enroll around 2,500 participants residing in the study area and with no intention to relocate in the next 2 years. Under this arm, all the relevant healthcare providers and their line managers will be provided training on preconception care. Healthcare providers will enroll the participants using their couple registrars to provide preconception care.

干预措施: Preconception care (PCC) (Behavioral)

结局指标

主要结局

Through baseline and end line questionnaire survey the study will assess the proportion of recently delivered women utilized skilled ANC, DC, and PNC services

时间窗: "through study completion, an average of 1 and half years"

To determine the Antenatal care (ANC), Delivery care (DC) and Postnatal care (PNC) uptake by skilled provider, the investigators will follow the criteria of Bangladesh Demographic and Health Survey (BDHS).

Through baseline and end line questionnaire survey the study will assess the percentage of study participants have proper knowledge about skilled MNCH services

时间窗: "through study completion, an average of 1 and half years"

How much knowledge for skilled MNCH care are increased will be measured from among the women who received preconception care and who did not receive preconception care. The investigators are anticipating 25% improvement from baseline to end line

Through baseline and end line questionnaire survey the study will assess the rate of knowledge and practices are increased in terms of modern FP methods among newlywed women

时间窗: "through study completion, an average of 1 and half years"

To determine the improvement status of respondent's knowledge and uptake of family planning methods, the investigators anticipating 25% improvement from baseline to end line.

Through baseline and end line questionnaire the study will assess the frequency of pregnancy related complications are reduced

时间窗: "through study completion, an average of 1 and half years"

How much pregnancy related complications are reduced will be assessed among the women who received preconception care compared to who did not receive preconception care.

次要结局

  • Through baseline and end line questionnaire survey the study will assess the rate of delaying first birth among the study participants'("through study completion, an average of 1 and half years")
  • Through baseline and end line questionnaire survey the study will assess the rate of unintended pregnancy among the study participants'("through study completion, an average of 1 and half years")

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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