Clinical trial NCT03930576: Consequences of Unwanted Pregnancy in Nepal
Official title: Pregnancy Context and Health
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Unwanted Pregnancy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Center for Research on Environment, Health and Population Activities
First posted: 2019-04-29
Enrollment: 1436
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The proposed study will be a large, longitudinal, prospective, quantitative study among women seeking termination services at 14 diverse facilities in 7 provinces (two facilities in each province) of Nepal. The specific facilities were randomly selected from a list of providers who served more than 60 women in FY 2016/17. Providers who serve more than 60 women per year make up 44% of all providers but provide 92% of termination services. One non-governmental organization and one public site was randomly selected within each of 7 provinces so that their chance of selection was proportionate to the number of women served. These sites are a representative sample of women seeking care.

Brief summary: The objective of this project is to examine the health consequences of unwanted pregnancy and denial of legal pregnancy termination services in Nepal on women and their children. The proposed study will be a large, longitudinal, prospective, quantitative study among women seeking termination services at 14 diverse facilities in 7 provinces (two facilities in each province) of Nepal. Every 6 months following baseline, surveys will cover questions about women's physical and mental health, the health and development of their children, as well as measures of family wellbeing, such as residency, relationship status and quality, and extended family relationships, and financial wellbeing, such as employment status, hours of labor, food security, income, and education.

Detailed description: The objective of this project is to examine the health consequences of unwanted pregnancy and denial of legal pregnancy termination services in Nepal on women and their children. Births following unwanted pregnancies can be associated with negative physical, social and economic consequences for both the woman and child. Half of all unintended pregnancies are terminated before they are carried to term and, when performed in unsafe or illegal conditions, the consequences can include infection, infertility, and death. The incidence of mortality and morbidity from abortion are notoriously difficult to measure. Widespread stigma associated with unwanted pregnancy - even in settings in which termination is legally available - contribute to misreporting, concealment, and misattribution of termination-related morbidity and mortality. In addition, many women seek illegal methods-both safe and unsafe-which further confounds efforts to measure the prevalence of mortality and morbidity from terminations. The effects of unwanted pregnancy on children, including children born prior to and subsequent to the unwanted pregnancy, are also not well established. A prospective longitudinal study of women with unwanted pregnancies is required to validly investigate the health consequences for women and their families of termination outside of the legal system and delivery of an unwanted pregnancy, as compared to legal termination. Such a study is only possible in places like Nepal, where termination is legal but barriers prevent some women from receiving the service.

Aim 1: To investigate the predictors of denial of legal pregnancy termination services and identify groups of women who may be at elevated risk of adverse sequelae from unwanted pregnancy.

Aim 2: To assess the health consequences for women of childbirth and illegal termination after denial of a legal termination. By comparing the two groups of women denied termination of pregnancy to those obtaining legal procedures, the study team will assess the health effects of denial while accounting for factors associated with experience of unwanted pregnancy.

Aim 3: To measure the effects of legal and illegal termination compared to birth on the health and development of women's existing and subsequent children

Prospective longitudinal data from women in a less developed country would provide valuable evidence for the development of programs and policies globally to improve access to and utilization of safe termination services where they are legal, and harm reduction services for women who are unable to access services.

Eligibility criteria: Inclusion Criteria:

* women
* seeking pregnancy termination services at one of the study facilities
* self-report last menstrual period to be at least 10 weeks ago or not know her gestational age
* 15 years old or older
* live in Nepal

Exclusion Criteria:

* under 15 years old
* not pregnant
* do not live in Nepal

Primary outcomes:
measure: Proportion experiencing denial of termination services on day of recruitment
timeFrame: 6 weeks
measure: Proportion of participants who did not receive a termination from an approved facility
timeFrame: 6 weeks
measure: Proportion of termination-seeking participants who received a termination
timeFrame: 6 months
measure: Proportion of existing children with stunting at 36 months
timeFrame: 36 months
measure: Maternal deaths during the study period
timeFrame: 36 months
measure: Proportion of women reporting poor health by 36 months
timeFrame: 36 months
measure: Proportion of subsequent children with stunting
timeFrame: 36 months
Secondary outcomes:
measure: Proportion experiencing violence from husband at each year of follow up
timeFrame: 36 months
measure: Proportion experiencing violence from any family members or close relatives other than husband at 36 months
timeFrame: 36 months
measure: Proportion reporting depression at 36 months
timeFrame: 36 months
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: CREHPA
Study officials:
affiliation: University of California, San Francisco
name: Diana G Foster, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CREHPA
name: Mahesh Puri, PhD
role: PRINCIPAL_INVESTIGATOR
References: