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Attitudes and Decision-making After Pregnancy Testing Study (ADAPT)

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ClinicalTrials.gov Identifier: NCT03888404
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

The ADAPT Study is a longitudinal observational cohort study examining women's pregnancy preferences, pregnancy decision-making processes, and the effects of less preferred (commonly called "unintended") pregnancy on women's lives. This study will enroll and follow prospectively an Underlying Cohort (UC) of women who are not pregnant at baseline. The study will measure the degree to which participants desire to avoid pregnancy multiple times over the course of the year and capture incident pregnancies as they occur over time. Participants experiencing new pregnancies during the one-year UC will be transferred into a new cohort, the Pregnancy and Match Cohort (PMC); these women will be followed over the course of their pregnancy decision-making and health care-seeking to document these processes. In addition, they will be followed through their pregnancies and giving birth to investigate differences in health, well-being, and socioeconomic outcomes associated with carrying a pregnancy to term based on the participant's pre- and post-pregnancy preference about the pregnancy. Finally, a cohort of non-pregnant women from the UC, matched on desire to avoid pregnancy and time at risk of pregnancy, will be followed as part of the PMC. The study will compare the health, well-being, and socioeconomic outcomes of women with new pregnancies and new births to those in the non-pregnant group to assess the effect of pregnancy itself on women.

The ADAPT study has the following aims:

Aim 1: Assess the factors associated with women's pregnancy preferences, how preferences change over time, and their associations with contraceptive use, incident pregnancy, and feelings about the pregnancy after discovery (Underlying Cohort)

Aim 2: Investigate the options that women consider when they become pregnant and the factors that influence their pregnancy decision-making and ability to access desired reproductive health care and services (prenatal, abortion, adoption) (Study A)

Aim 3a: Examine the effects of giving birth from a less preferred (or "unintended") pregnancy, measured prospectively on a continuum, as compared to a more preferred pregnancy, on women's health and well-being (Study B1)

Aim 3b: Examine the effects of experiencing pregnancy and birth on women's health and well-being, as compared to not experiencing pregnancy (Study B2)

This is a social science, behavioral study and does not use clinical data or biological markers.


Condition or disease Intervention/treatment
Unintended Pregnancy Undesired Pregnancy Other: Pregnancy preferences (Aim 1) Other: Sociocultural environment (Aim 2) Other: Pregnancy preferences (Aim 3a) Other: Pregnancy (Aim 3b)

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Study Type : Observational
Estimated Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Attitudes and Decision-making After Pregnancy Testing Study
Actual Study Start Date : March 16, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Group/Cohort Intervention/treatment
Underlying Cohort
The study will recruit and follow a prospective cohort of women "at risk" of pregnancy for one year.
Other: Pregnancy preferences (Aim 1)
The primary exposure of interest for Aim 1 will be pregnancy preferences, measured with the Desire to Avoid Pregnancy scale.

Pregnancy Match Cohort, Pregnant Group
Women from the Underlying Cohort who become pregnant will be transferred into the Pregnancy Match Cohort to be followed for two years.
Other: Sociocultural environment (Aim 2)
For Aim 2 will assess the roles of contextual and individual variables on pregnancy decision-making and care-seeking outcomes (including state political environment, stigma, social emotional and instrumental support, feelings about the pregnancy, SES).

Other: Pregnancy preferences (Aim 3a)
The primary exposure of interest for Aim 3a will be pregnancy preferences, measured with the Desire to Avoid Pregnancy scale.

Pregnancy Match Cohort, Not Pregnant Group
The study will also follow a comparison cohort of non-pregnant women from the Underlying Cohort, frequency matched to the pregnant participants on Desire to Avoid Pregnancy score and time at risk of pregnancy.
Other: Pregnancy (Aim 3b)
The exposure of interest for Aim 3b will be experiencing pregnancy. DAP level will be examined as an effect modifier.




Primary Outcome Measures :
  1. Mean score on Cohen's Perceived Stress Scale over 24 months (Aims 3a/3b) [ Time Frame: PMC baseline through 24 months ]
    The Perceived Stress Scale (PSS) measures stress; scores are summed across 4 scale items (brief version), each with responses never to very often, on a 5-point scale, for a score ranging 0-16. The outcome will be the predicted mean PSS score over the 8 PMC survey observations (a single measure of effect), based on the marginal effect from a longitudinal multivariable mixed effects model.

  2. Proportion experiencing moderate to severe depressive symptoms on the PHQ-8 over 24 months (Aims 3a/3b) [ Time Frame: PMC baseline through 24 months ]
    Patient Health Questionnaire (PHQ-8) measures depression symptoms; scores are summed across the 8 items, each with responses not at all to nearly every day, on a 4-point scale, for a score ranging 0-24. Those scoring ≥ 10 are considered to have moderate to severe depression. The outcome will be the predicted probability of a PHQ-8 score ≥ 10 over the 8 PMC survey observations (a single measure of effect), based on the marginal effect from a longitudinal multivariable mixed effects model.

  3. Proportion experiencing moderate to severe anxiety symptoms on the GAD-7 over 24 months (Aims 3a/3b) [ Time Frame: PMC baseline through 24 months ]
    Generalized Anxiety Disorder (GAD-7) measures anxiety symptoms; scores are summed across the 7 items, each with responses not at all to nearly every day, on a 4-point scale, for a score ranging 0-21. Those scoring ≥ 10 are considered to have moderate to severe anxiety. The outcome will be the predicted probability of a GAD-7 score ≥ 10 over the 8 PMC survey observations (a single measure of effect), based on the marginal effect from a longitudinal multivariable mixed effects model.

  4. Proportion of pregnancies ending in childbirth and childraising, among those who reported ever considering the option (Aim 2) [ Time Frame: PMC baseline through 12 months ]
    Participants will report at each survey whether they considered each pregnancy option, as well as the status and outcome of their pregnancy. The outcome will be the proportion of participants whose pregnancies ended in childbirth and childraising, among those who ever reported considering giving birth and raising the child on a follow-up survey.

  5. Proportion of pregnancies ending in abortion, among those who reported ever considering the option (Aim 2) [ Time Frame: PMC baseline through 12 months ]
    Participants will report at each survey whether they considered each pregnancy option, as well as the status and outcome of their pregnancy. The outcome will be the proportion of participants whose pregnancies ended in abortion, among those who ever reported considering abortion on a follow-up survey.

  6. Proportion of participants obtaining prenatal care, among those who ever reported seeking prenatal care (Aim 2) [ Time Frame: PMC baseline through 12 months ]
    Participants will report at each survey whether they sought prenatal care, abortion care and/or adoption services and whether they obtained each type of care. The outcome will be the proportion of participants who obtained prenatal care, among those who ever reported seeking prenatal care.

  7. Proportion of participants obtaining abortion care, among those who ever reported seeking abortion care (Aim 2) [ Time Frame: PMC baseline through 12 months ]
    Participants will report at each survey whether they sought prenatal care, abortion care and/or adoption services and whether they obtained each type of care. The outcome will be the proportion of participants who obtained abortion care, among those who ever reported seeking abortion care.


Secondary Outcome Measures :
  1. Proportion living below 100% of the Federal Poverty Level (FPL) (Aims 3a/3b) [ Time Frame: PMC baseline through 24 months ]
    Participants will report on all surveys their household income and size. We will calculate the FPL cut-point based on the specific year's US Census Bureau FPL. The outcome will be the predicted probability of living below 100% FPL over the 8 PMC survey observations, based on the marginal effect from a longitudinal multivariable mixed effects model.

  2. Mean MacArthur Scale of Subjective Social Status score over 24 months (Aims 3a/3b) [ Time Frame: PMC baseline through 24 months ]
    Participants will rank themselves on the MacArthur Scale of Subjective Social Status (SSS) ladder (1-10) at all surveys. The outcome will be the predicted mean score over the 8 PMC survey observations, based on the marginal effect from a longitudinal multivariable mixed effects model.

  3. Proportion employed full or part time (Aims 3a/3b) [ Time Frame: PMC baseline through 24 months ]
    Participants will report on all surveys their current employment status. The outcome will be the predicted probability of being employed (full or part time) over the 8 PMC survey observations, based on the marginal effect from a longitudinal multivariable mixed effects model.

  4. Time until dropping out of or leaving school (Aims 3a/3b) [ Time Frame: PMC baseline through 24 months ]
    Participants will respond to questions at each survey about their current enrollment in school, type of school attended, degree sought, changes in enrollment since prior survey, degree completion/incompletion, and educational aspirations. Dropping out will be examined as, among those in a degree or other educational program at PMC baseline, time until stopping the degree for a reason other than completion.

  5. Mean Diener's Flourishing Scale scores over 24 months (Aims 3a/3b) [ Time Frame: PMC baseline through 24 months ]
    Diener's Flourishing Scale scores measures eudaimonic well-being; scores are summed across the 8 items, each with responses strongly agree to strongly disagree, on a 7-point scale, for total scores of 0-46. The outcome will be the predicted mean scale score over the 8 PMC survey observations, based on the marginal effect from a longitudinal multivariable mixed effects model.


Other Outcome Measures:
  1. Proportion drinking any alcohol in the last month during pregnancy (Aims 3a/3b) [ Time Frame: PMC baseline through 9 months, during pregnancy ]
    Participants will report at each survey how often they had a drink with alcohol in the last month. The outcome will be the predicted probability of drinking alcohol over PMC survey observations during which participants are pregnant, based on the marginal effect from a longitudinal multivariable mixed effects model.

  2. Proportion drinking more than four drinks at a time in the last month (Aims 3a/3b) [ Time Frame: PMC baseline through 24 months ]
    Participants will report at each survey how often they drank four or more alcoholic drinks at a time (heavy episodic drinking) in the last month. The outcome will be the predicted probability of heavy episodic drinking over the 8 PMC survey observations, based on the marginal effect from a longitudinal multivariable mixed effects model.

  3. Proportion reporting physical and/or emotional intimate partner violence (IPV) from the man involved in the pregnancy in the last three months (Aim 3a) [ Time Frame: PMC baseline through 24 months ]
    Participants will report at each survey whether the man involved in their pregnancy physically hurt them (physical IPV) or swore at or controlled their behavior (emotional IPV) in the last three months (minors excluded). The outcome will be the predicted probability of experiencing either type of IPV over the 8 PMC survey observations, based on the marginal effect from a longitudinal multivariable mixed effects model.

  4. Proportion reporting their current physical health to be fair or poor, based on an adapted version of the SF-36 self-rated health item (Aims 3a/3b) [ Time Frame: PMC baseline through 24 months ]
    Participants will respond at each survey to the question about how they rate their current physical health (excellent, very good, good, fair, poor). This self-rated health question is an adaptation of the item on the RAND Medical Outcomes Survey (SF-36) and the item used in the World Health Organization's World Health Survey. The outcome will be the predicted probability of fair/poor physical health over the 8 PMC survey observations, based on the marginal effect from a longitudinal multivariable mixed effects model.

  5. Proportion of babies born prior to 37 weeks gestation (Aim 3a) [ Time Frame: PMC follow-up survey (6 weeks through 24 months) at which birth is first reported ]
    In the PMC follow-up survey at which participants report having given birth, they will report the date that doctors expected the baby would be born and the actual birth date. Premature birth will be considered a birth occurring prior to three weeks before the due date.

  6. Proportion at risk of poor bonding on the Postpartum Bonding Questionnaire (Aims 3a) [ Time Frame: PMC follow-up surveys (6 weeks through 24 months), starting at the survey at which birth is first reported ]
    Participants will respond at each survey after the birth of the index child to the Brockington Postpartum Bonding Questionnaire, a 12-item scale, with responses on a 5-point scale from all of the time to never, total range 0-48. A score of ≥12 is considered to indicate risk of poor bonding. The outcome will be the predicted probability of being at risk of poor bonding over the 8 PMC survey observations, based on the marginal effect from a longitudinal multivariable mixed effects model.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 34 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female, trans-men, and gender non-conforming/queer people with uterus
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women seeking care at participating reproductive health and primary care facilities
Criteria

Inclusion Criteria:

  • Aged 15 to 34
  • Is presenting for services at the participating recruitment site
  • Speaks and reads English or Spanish
  • Sexually active (has had sex in the last 3 months with a man/someone with sperm)
  • Has a uterus (assigned female at birth)
  • Resides in a study state or one directly bordering a study state
  • Has access to a phone, internet, or smartphone
  • Willing to be contacted by research team for 1-3 years by phone and either email or mail

Exclusion Criteria:

  • Reports current pregnancy (unless having or initiating an abortion on the day of enrollment)
  • Is sterilized or using an intrauterine device or transdermal implant at enrollment

Information from the National Library of Medicine

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): NCT03888404


Contacts
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Contact: Heather Gould, MPH 1-510-986-8936 heather.gould@ucsf.edu
Contact: Isabel Munoz, MPH 1-510-986-8970 isabel.munoz@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
Oakland, California, United States, 94612
Contact: Research Associate         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Corinne Rocca, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03888404    
Other Study ID Numbers: 17-23592
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Unintended Pregnancy
Unintended Birth
Pregnancy Preferences
Pregnancy Desires
Prenatal Care
Abortion
Adoption
Pregnancy Decision-Making
Mental Health
Stress
Socioeconomic Status
Education