Attitudes and Decision-making After Pregnancy Testing Study

NCT03888404 | Active Not Recruiting

• 2 other identifiers: 17-23592R01HD108643
• Study Type: observational
• Target: 2,015
• Locations: 1 country
• Sites: 1

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.

Conditions

Unintended Pregnancy; Undesired Pregnancy

Keywords

Unintended Pregnancy; Unintended Birth; Pregnancy Preferences; Pregnancy Desires; Prenatal Care; Abortion; Adoption; Pregnancy Decision-Making; Mental Health; Stress; Socioeconomic Status; Education

Outcome Measures

Primary Outcomes (7)

• Mean score on Cohen's Perceived Stress Scale over 24 months (Aims 3a/3b)

  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.

  PMC baseline through 24 months

• Proportion experiencing moderate to severe depressive symptoms on the PHQ-8 over 24 months (Aims 3a/3b)

  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.

  PMC baseline through 24 months

• Proportion experiencing moderate to severe anxiety symptoms on the GAD-7 over 24 months (Aims 3a/3b)

  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.

  PMC baseline through 24 months

• Proportion of pregnancies ending in childbirth and childraising, among those who reported ever considering the option (Aim 2)

  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.

  PMC baseline through 12 months

• Proportion of pregnancies ending in abortion, among those who reported ever considering the option (Aim 2)

  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.

  PMC baseline through 12 months

• Proportion of participants obtaining prenatal care, among those who ever reported seeking prenatal care (Aim 2)

  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.

  PMC baseline through 12 months

• Proportion of participants obtaining abortion care, among those who ever reported seeking abortion care (Aim 2)

  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.

  PMC baseline through 12 months

Secondary Outcomes (5)

• Proportion living below 100% of the Federal Poverty Level (FPL) (Aims 3a/3b)

  PMC baseline through 24 months

• Mean MacArthur Scale of Subjective Social Status score over 24 months (Aims 3a/3b)

  PMC baseline through 24 months

• Proportion employed full or part time (Aims 3a/3b)

  PMC baseline through 24 months

• Time until dropping out of or leaving school (Aims 3a/3b)

  PMC baseline through 24 months

• Mean Diener's Flourishing Scale scores over 24 months (Aims 3a/3b)

  PMC baseline through 24 months

Other Outcomes (6)

• Proportion drinking any alcohol in the last month during pregnancy (Aims 3a/3b)

  PMC baseline through 9 months, during pregnancy

• Proportion drinking more than four drinks at a time in the last month (Aims 3a/3b)

  PMC baseline through 24 months

• Proportion reporting physical and/or emotional intimate partner violence (IPV) from the man involved in the pregnancy in the last three months (Aim 3a)

  PMC baseline through 24 months

Study Arms (3)

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)

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); Other: Pregnancy preferences (Aim 3a)

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)

Interventions

Pregnancy preferences (Aim 1) OTHER

The primary exposure of interest for Aim 1 will be pregnancy preferences, measured with the Desire to Avoid Pregnancy scale.

Underlying Cohort

Sociocultural environment (Aim 2) OTHER

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).

Pregnancy Match Cohort, Pregnant Group

Pregnancy preferences (Aim 3a) OTHER

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

Pregnancy Match Cohort, Pregnant Group

Pregnancy (Aim 3b) OTHER

The exposure of interest for Aim 3b will be experiencing pregnancy. DAP level will be examined as an effect modifier.

Pregnancy Match Cohort, Not Pregnant Group

Eligibility Criteria

• Age: 15 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women seeking care at participating reproductive health and primary care facilities

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of California, San Francisco

Oakland, California, 94612, United States

Location

Related Publications (1)

• Rocca CH, Gould H, Gonzalez E, Foster DG, Munoz I, Parra M, Ralph LJ. Cohort profile: the ADAPT study, a prospective study of pregnancy preferences, pregnancy, and health and well-being in the southwestern USA. BMJ Open. 2024 Sep 25;14(9):e085372. doi: 10.1136/bmjopen-2024-085372.

  PMID: 39322600 RESULT

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Corinne Rocca, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 25, 2019
• Study Start: March 16, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)