Clinical trial NCT05240066: Birth Control to Improve Birth Spacing
Official title: Birth Control to Improve Birth Spacing: a Prospective Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Contraception
Contraception Behavior
Knowledge, Attitudes, Practice
Birth Spacing
Keywords: birth spacing
behavior
environmental barriers
pospartum
contraception
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
name: Harvard Medical School (HMS and HSDM)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-02-15
Enrollment: 1341
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will enroll 1,400 patients into the prospective cohort, selecting individuals enrolled at prenatal care visits at Boston Medical Center and Brigham and Women's Hospital main campus. All subjects enrolled in the baseline survey who deliver at enrollment sites will be included in electronic medical records and contacted for a follow-up survey at 12 weeks postpartum.

Additionally, the investigators will invite a subset of the study subjects (25-30 patients) who report significant barriers to contraceptive uptake in the 12-week postpartum follow up survey to participate in qualitative interviews.

Brief summary: This study aims to investigate the drivers of postpartum contraceptive use with a prospective cohort. The study will clarify the role of contraceptive knowledge, attitudes, norms, and self-efficacy in driving intention to initiate contraception postpartum and describe the impact of environmental barriers on enacting intended postpartum contraception initiation.

Detailed description: This study will be a sequential mixed-methods design with a prospective cohort to identify and explore barriers to contraceptive initiation both immediately after birth and prior to hospital discharge, as well as throughout the fourth trimester. It will include a baseline patient survey, electronic medical record data pull, follow up survey, and qualitative interviews.

The investigators will enroll 1400 patients into the prospective cohort, selecting individuals enrolled at prenatal care visits at two sites. The baseline survey will be self-administered. The investigators will then contact participants for a follow-up survey at 12 weeks postpartum. Surveys will be self-administered through a link received by text message or email. Additional analyses will draw on retrospectively collected medical record data.

The investigators will invite a subset of 25-30 study subjects to participate in qualitative interviews.

Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Pregnant
* Attending prenatal care visits at one of the two study sites

Exclusion Criteria:

* Under the age of 18
* Cannot complete a survey in English or Spanish
* Do not have physical or cognitive ability to complete a survey on a tablet

Primary outcomes:
measure: Desired birth spacing
timeFrame: Baseline
measure: Contraceptive attitudes and norms
timeFrame: Baseline
measure: contraceptive self-efficacy
timeFrame: Baseline
measure: Contraceptive knowledge
timeFrame: Baseline
measure: Intention to initiate contraception postpartum
timeFrame: Baseline
measure: Planned postpartum contraceptive method
timeFrame: Baseline
measure: Contraceptive use
timeFrame: 12-week follow up
measure: Environmental barriers to contraceptive use
timeFrame: 12-week follow up
Secondary outcomes:
measure: Intimate partner violence
timeFrame: 12-week follow up
Other outcomes:
measure: Immediate and delayed postpartum method uptake
timeFrame: 72 hours postpartum, 12 weeks postpartum
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
References: