Effect of Formal Contraception Handouts

NCT03956030 | Terminated Results

• 1 other identifier: STUDY00012248
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this study is to determine if distribution of a standardized educational handout on contraceptive options given to patients in the prenatal office setting will increase contraception use six months postpartum.

Conditions

Contraception; Counseling

Keywords

Female Contraception; Education

Outcome Measures

Primary Outcomes (1)

• Contraception Use

  Participants were sent a survey electronically at 8 weeks which asked the question "Now that you have delivered, are you currently using birth control? (yes or no)" The data table reflects the number who answered YES and the number who answered NO to this question per group.

  8 weeks postpartum

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group will receive educational handout on contraception.

Other: Contraception Handout

Control

EXPERIMENTAL

Control group will receive educational handout on nutrition.

Other: Nutritional Handout

Interventions

Contraception Handout OTHER

Handout covering contraception options

Intervention

Nutritional Handout OTHER

Handout covering nutrition

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study will recruit women who are 24-28 weeks gestational age.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are pregnant and are 24-28 weeks gestational age at the time of recruitment
• Women \>18 years of age
• Women with low-risk pregnancies

You may not qualify if:

• Women who receive prenatal care by the Maternal Fetal Medicine department for high-risk pregnancies
• Women who are members of an at-risk population including any women who is a prisoner, cannot provide consent, or is \<18 years of age
• Non-English speaking

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Women's Health Center

Hershey, Pennsylvania, 17033, United States

Location

Limitations and Caveats

Termination of the study leading to small number of subjects analyzed.

Results Point of Contact

• Title: Dr. Christina DeAngelis
• Organization: Penn State Health, Milton S. Hershey Medical Center

cdeangelis2@pennstatehealth.psu.edu

717-531-5994

Study Officials

• Christina DeAngelis, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Women's Health Division

Model Details: Randomized controlled trial in which the intervention group will receive an educational handout on contraception and the control group will receive a handout on nutrition.

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: September 10, 2020
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2021
• Last Updated: March 30, 2023
• Results First Posted: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)