Consequences of Unwanted Pregnancy in Nepal

NCT ID: NCT03930576

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1436 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2028-12-15

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.

Conditions

Unwanted Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early Legal Terminations

Participants who receive a legal termination at \<10 weeks gestation at a recruiting facility.

No interventions assigned to this group

Late Legal Terminations

Participants who receive a legal termination at 10+ weeks gestation at a recruiting facility.

No interventions assigned to this group

Turn-aways: Termination outside Legal Setting

Participants who receive a termination at another facility or outside the formal healthcare sector.

Receipt of termination services outside of legal setting

Intervention Type: OTHER

This study uses variation in gestational age to examine the impact of receipt of legal termination services compared to denial and receipt outside legal settings and birth.

Turn-aways: Birth

Participants who ultimately carry the pregnancy to term

No interventions assigned to this group

Interventions

Receipt of termination services outside of legal setting

This study uses variation in gestational age to examine the impact of receipt of legal termination services compared to denial and receipt outside legal settings and birth.

Intervention Type: OTHER

Other Intervention Names

Carrying unwanted pregnancy to term

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Center for Research on Environment, Health and Population Activities

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diana G Foster, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Mahesh Puri, PhD

Role: PRINCIPAL_INVESTIGATOR

CREHPA

Locations

CREHPA

Kathmandu, , Nepal

Countries

Nepal

Other Identifiers

18-25863

Identifier Type: -

Identifier Source: org_study_id