Effect of Formal Contraception Handouts

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03956030
Collaborator
(none)
200
1
2
27.6
7.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Contraception Handout
  • Other: Nutritional Handout
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Formal Contraception Handouts on Postpartum Birth Control Use and Methods
Actual Study Start Date :
Sep 10, 2020
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Intervention group will receive educational handout on contraception.

Other: Contraception Handout
Handout covering contraception options

Experimental: Control

Control group will receive educational handout on nutrition.

Other: Nutritional Handout
Handout covering nutrition

Outcome Measures

Primary Outcome Measures

  1. Contraception Use [8 weeks postpartum]

    Contraception use defined as yes or no (as reported by the patient)

Secondary Outcome Measures

  1. Contraception Use [6 months postpartum]

    Contraception use defined as yes or no (as reported by the patient)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women's Health Center Hershey Pennsylvania United States 17033

Sponsors and Collaborators

  • Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Christina DeAngelis, MD, Milton S. Hershey Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christina DeAngelis, Assistant Professor Women's Health Division, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT03956030
Other Study ID Numbers:
  • STUDY00012248
First Posted:
May 20, 2019
Last Update Posted:
Jan 19, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christina DeAngelis, Assistant Professor Women's Health Division, Milton S. Hershey Medical Center

Study Results

No Results Posted as of Jan 19, 2022