Clinical trial NCT03956030: Effect of Formal Contraception Handouts
Official title: Effect of Formal Contraception Handouts on Postpartum Birth Control Use and Methods
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Contraception
Counseling
Keywords: Female Contraception
Education
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Contraception Use
timeFrame: 8 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Women's Health Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Christina DeAngelis, MD
role: PRINCIPAL_INVESTIGATOR
References: