Effect of Formal Contraception Handouts

Contraception Clinical Trial

Official title:

Effect of Formal Contraception Handouts on Postpartum Birth Control Use and Methods

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03956030
• Other study ID #: STUDY00012248
• Status: Terminated
• Phase: N/A
• Start date: September 10, 2020
• Est. completion date: September 8, 2021

Study information

• Verified date: March 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 8, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Counseling

Intervention

Other:
• Contraception Handout
Handout covering contraception options
• Nutritional Handout
Handout covering nutrition

Locations

Country	Name	City	State
United States	Women's Health Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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