Unwanted PregnancyNCT03930576
Consequences of Unwanted Pregnancy in Nepal
An observational study of Unwanted Pregnancy, run by University of California, San Francisco at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unwanted Pregnancy
- What is being tested?
- Receipt of termination services outside of legal setting
- How many people
- 1,436 participants
- Where
- 1 siteNepal
- Study dates
- 16 Apr 2019to 15 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- under 15 years old
- not pregnant
- do not live in Nepal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pregnancy Context and Health
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.
Read the 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
- Being tested
- Receipt of termination services outside of legal setting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receipt of termination services outside of legal settingOther
Also called Carrying unwanted pregnancy to term
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Receipt of termination services outside of legal setting | |
| Turn-aways: Birth | Participants who ultimately carry the pregnancy to term |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 months
Secondary outcomes (3)
Proportion experiencing violence from husband at each year of follow up
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).
Measured: 36 months
Proportion experiencing violence from any family members or close relatives other than husband at 36 months
Self-reported violence from family members or close relatives other than husband or partner (yes/no) in the past 12 months.
Measured: 36 months
Proportion reporting depression at 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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start16 Apr 2019
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unwanted PregnancyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Research on Environment, Health and Population Activities
- Responsible party
- Sponsor
- Investigators
- Diana G Foster, PhD, Principal investigator, University of California, San FranciscoMahesh Puri, PhD, Principal investigator, CREHPA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03930576
- Sponsor's protocol ID
- 18-25863
- Status last verified
- Mar 2026
- First submitted
- 22 Apr 2019
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murro R, Raifman S, Boscardin WJ, Puri MC, Karki S, Magar AA, Maharjan DC, Rocca CH, Biggs MA, Diamond-Smith NG, Foster DG. Cohort profile: The Nepal Turnaway Study. medRxiv [Preprint]. 2026 Mar 28:2026.03.10.26348060. doi: 10.64898/2026.03.10.26348060.
PubMed 41929341
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Context and Health
- ClinicalTrials.gov ID
- NCT03930576
- Acronym / sponsor ID
- 18-25863
- Conditions
- Unwanted Pregnancy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,436 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Center for Research on Environment, Health and Population Activities
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Receipt of termination services outside of legal settingParticipants who receive a termination at another facility or outside the formal healthcare sector. |
| Turn-aways: Birth | – | –Participants who ultimately carry the pregnancy to term |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- under 15 years old
- not pregnant
- do not live in Nepal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receipt of termination services outside of legal settingAlso: Carrying unwanted pregnancy to termThis 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 | Turn-aways: Termination outside Legal Setting |
Primary outcome
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.
3 secondary outcomes
Proportion experiencing violence from husband at each year of follow up
Time frame: 36 months
Proportion experiencing violence from any family members or close relatives other than husband at 36 months
Time frame: 36 months
Proportion reporting depression at 36 months
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Derived from this study: PubMed 41929341Murro R, Raifman S, Boscardin WJ, Puri MC, Karki S, Magar AA, Maharjan DC, Rocca CH, Biggs MA, Diamond-Smith NG, Foster DG. Cohort profile: The Nepal Turnaway Study. medRxiv [Preprint]. 2026 Mar 28:2026.03.10.26348060. doi: 10.64898/2026.03.10.26348060.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana G Foster, PhD principal investigator
University of California, San Francisco
Mahesh Puri, PhD principal investigator
CREHPA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unwanted Pregnancy, run by University of California, San Francisco at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion experiencing denial of termination services on day of recruitment (time frame: 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03930576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.