Effect of Formal Contraception Handouts

Study Overview
=================
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.

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

Conditions
-----------------
Contraception, Counseling

Intervention / Treatment
-----------------
* Other: Contraception Handout
* Other: Nutritional Handout


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Intervention group will receive educational handout on contraception. | Other: Contraception Handout<br>* Handout covering contraception options<br>|
| Experimental: Control<br>Control group will receive educational handout on nutrition. | Other: Nutritional Handout<br>* Handout covering nutrition<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Female Contraception, Education