Consequences of Unwanted Pregnancy in Nepal

NCT03930576 | Active Not Recruiting

• 1 other identifier: 18-25863
• Study Type: observational
• Target: 1,436
• Locations: 1 country
• Sites: 1

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.

Conditions

Unwanted Pregnancy

Outcome Measures

Primary Outcomes (7)

• Proportion experiencing denial of termination services on day of recruitment

  This will be defined as the proportion of participants who did not receive termination services on the day they were recruited at the clinic site where they are recruited in to the study.

  6 weeks

• Proportion of participants who did not receive a termination from an approved facility

  Proportion of participants who did not receive termination services from the recruitment clinic and did not receive a termination at any facility that they were referred to by the recruitment facility

  6 weeks

• Proportion of termination-seeking participants who received a termination

  Participants will report their pregnancy outcome at 6 months; the proportion of participants who had an abortion by 6 months versus had a miscarriage, gave birth, or were still pregnant.

  6 months

• Proportion of existing children with stunting at 36 months

  The proportion of children existing at the time of termination-seeking who having stunting, or low height-for-age, defined according to the World Health Organization as less than two standard deviations of the World Health Organization Child Growth Standards median.

  36 months

• Maternal deaths during the study period

  Proportion of maternal deaths by end of study. The study team will implement a verbal autopsy protocol for any women who die during the study period, with a particular focus on identifying specific pregnancy-related causes of death.

  36 months

• Proportion of women reporting poor health by 36 months

  The proportion of participants who self-report poor or very poor physical health by 36 months.

  36 months

• Proportion of subsequent children with stunting

  The proportion of subsequent children born to participants after the index pregnancy who having stunting, or low height-for-age, defined according to the World Health Organization as less than two standard deviations of the World Health Organization Child Growth Standards median.

  36 months

Secondary Outcomes (3)

• Proportion experiencing violence from husband at each year of follow up

  36 months

• Proportion experiencing violence from any family members or close relatives other than husband at 36 months

  36 months

• Proportion reporting depression at 36 months

  36 months

Study Arms (4)

Early Legal Terminations

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

Late Legal Terminations

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

Turn-aways: Termination outside Legal Setting

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

Other: Receipt of termination services outside of legal setting

Turn-aways: Birth

Participants who ultimately carry the pregnancy to term

Interventions

Receipt of termination services outside of legal setting 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.

Also known as: Carrying unwanted pregnancy to term

Turn-aways: Termination outside Legal Setting

Eligibility Criteria

• Age: 15 Years+
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• years old or older
• live in Nepal

You may not qualify if:

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

Sponsors & Collaborators

• Center for Research on Environment, Health and Population Activities: collaborator
• University of California, San Francisco: lead

Study Sites (1)

CREHPA

Kathmandu, Nepal

Location

Study Officials

• Diana G Foster, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Mahesh Puri, PhD

  CREHPA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: April 29, 2019
• Study Start: April 16, 2019
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)