Effect of Formal Contraception Handouts

Not Applicable

Terminated

• Conditions: Counseling; Contraception
• Interventions: Other: Contraception Handout; Other: Nutritional Handout

• Registration Number: NCT03956030
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Detailed Description

Reducing unintended pregnancies and those that are conceived within 18 months of a previous livebirth is an important health concern in the United States. Both unintended and close-interval pregnancies constitute 40% and 35% of pregnancies in the United States respectively with some overlap between the two categories and are associated with adverse maternal and fetal outcomes. A national survey found that 17.8% of women using 'less-effective' methods and 23% of women using no birth control became pregnant in ≤18 months2. Access to better contraception education could potentially decrease the proportion of unintended pregnancies and close-interval pregnancies. In addition to the health concerns, 58% of women in the US would like more information about contraceptive options, and organized handouts on birth control have been shown to contribute to the choice in birth control. However, there has been conflicting evidence about which educational methods increase postpartum contraception use. Therefore, the investigators propose a randomized controlled trial (RCT) that assesses whether a handout on contraception options increases postpartum birth control use. The control group would receive a nutrition handout, and the intervention group would receive a handout on birth control options in addition to each receiving the standard of care. The researchers would also give pre- and post-natal questionnaires, covering patient satisfaction, intention to use birth control, and how often a provider discusses birth control options.

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-20
• Study Start: 2020-09-10
• Primary Completion: 2021-09-08
• Study Completion: 2021-09-08
• Results First Submitted: 2022-06-07
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-28
• Last Update Submitted: 2023-03-28
• Results First Posted: 2023-03-30
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

1. Women who are pregnant and are 24-28 weeks gestational age at the time of recruitment
2. Women >18 years of age
3. Women with low-risk pregnancies

Exclusion Criteria

1. Women who receive prenatal care by the Maternal Fetal Medicine department for high-risk pregnancies
2. 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
3. Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Contraception Handout	Intervention group will receive educational handout on contraception.
Control	Nutritional Handout	Control group will receive educational handout on nutrition.

Primary Outcome Measures

Name	Time	Method
Contraception Use	8 weeks postpartum	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.

Trial Locations

Locations (1)

Women's Health Center; 🇺🇸 Hershey, Pennsylvania, United States