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
|Condition or disease||Intervention/treatment|
|Unwanted Pregnancy||Other: Receipt of termination services outside of legal setting|
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|
|Estimated Enrollment :||1436 participants|
|Official Title:||Pregnancy Context and Health|
|Actual Study Start Date :||April 16, 2019|
|Estimated Primary Completion Date :||April 15, 2024|
|Estimated Study Completion Date :||June 15, 2024|
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
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
Participants who ultimately carry the pregnancy to term
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930576
|Contact: Diana G Foster, PhDemail@example.com|
|Contact: Sarah Raifman, MSfirstname.lastname@example.org|
|Contact: Mahesh Puri|
|Principal Investigator:||Diana G Foster, PhD||University of California, San Francisco|
|Principal Investigator:||Mahesh Puri, PhD||CREHPA|