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Consequences of Unwanted Pregnancy in Nepal

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ClinicalTrials.gov Identifier: NCT03930576
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
CREHPA
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date April 22, 2019
First Posted Date April 29, 2019
Last Update Posted Date November 18, 2019
Actual Study Start Date April 16, 2019
Estimated Primary Completion Date April 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2019)
  • Proportion experiencing denial of termination services on day of recruitment [ Time Frame: 6 weeks ]
    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.
  • Proportion of participants who did not receive a termination from an approved facility [ Time Frame: 6 weeks ]
    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
  • Proportion of termination-seeking participants who received a termination [ Time Frame: 6 months ]
    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.
  • Proportion of existing children with stunting at 36 months [ Time Frame: 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.
  • Maternal deaths during the study period [ Time Frame: 36 months ]
    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.
  • Proportion of women reporting poor health by 36 months [ Time Frame: 36 months ]
    The proportion of participants who self-report poor or very poor physical health by 36 months.
  • Proportion of subsequent children with stunting [ Time Frame: 36 months ]
    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.
Original Primary Outcome Measures
 (submitted: April 26, 2019)
  • Proportion experiencing denial of termination services on day of recruitment [ Time Frame: 6 weeks ]
    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.
  • Proportion of participants who did not receive a termination from an approved facility [ Time Frame: 6 weeks ]
    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
  • Proportion of termination-seeking participants who received a termination [ Time Frame: 6 months ]
    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.
  • Proportion of existing children with stunting at 36 months [ Time Frame: 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 WHO Child Growth Standards median.
  • Maternal deaths during the study period [ Time Frame: 36 months ]
    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.
  • Proportion of women reporting poor health by 36 months [ Time Frame: 36 months ]
    The proportion of participants who self-report poor or very poor physical health by 36 months.
  • Proportion of subsequent children with stunting [ Time Frame: 36 months ]
    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 WHO Child Growth Standards median.
Change History
Current Secondary Outcome Measures
 (submitted: April 26, 2019)
  • Proportion experiencing violence from husband at each year of follow up [ Time Frame: 36 months ]
    Proportion experiencing any physical violence from husband over time (12 months, 24 months, 36 months), defined pushed you, shake you, throw something at you (yes/no), slapped you (yes/no), twisted your arm or pulled your hair (yes/no), punched you (yes/no), kicked you (yes/no), tried to choke you (yes/no), threatened or attacked you with a weapon (yes/no).
  • Proportion experiencing violence from any family members or close relatives other than husband at 36 months [ Time Frame: 36 months ]
    Self-reported violence from family members or close relatives other than husband or partner (yes/no) in the past 12 months.
  • Proportion reporting depression at 36 months [ Time Frame: 36 months ]
    Proportion of participants self-reporting feeling down, depressed or hopeless nearly every day, more than half the days, or several days in the prior two weeks.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Consequences of Unwanted Pregnancy in Nepal
Official Title Pregnancy Context and Health
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Unwanted Pregnancy
Intervention Other: 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.
Other Name: Carrying unwanted pregnancy to term
Study Groups/Cohorts
  • 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.
    Intervention: Other: Receipt of termination services outside of legal setting
  • Turn-aways: Birth
    Participants who ultimately carry the pregnancy to term
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 26, 2019)
1436
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 15, 2024
Estimated Primary Completion Date April 15, 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Diana G Foster, PhD 510-986-8940 diana.greenefoster@ucsf.edu
Contact: Sarah Raifman, MS sarah.raifman@ucsf.edu
Listed Location Countries Nepal
Removed Location Countries  
 
Administrative Information
NCT Number NCT03930576
Other Study ID Numbers 18-25863
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor University of California, San Francisco
Collaborators CREHPA
Investigators
Principal Investigator: Diana G Foster, PhD University of California, San Francisco
Principal Investigator: Mahesh Puri, PhD CREHPA
PRS Account University of California, San Francisco
Verification Date November 2019