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Effect of Formal Contraception Handouts

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03956030
Enrollment
8
Registered
2019-05-20
Start date
2020-09-10
Completion date
2021-09-08
Last updated
2023-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception, Counseling

Keywords

Female Contraception, Education

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.

Interventions

OTHERContraception Handout

Handout covering contraception options

OTHERNutritional Handout

Handout covering nutrition

Sponsors

Milton S. Hershey Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Contraception Use8 weeks postpartumParticipants 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
Intervention group will receive educational handout on contraception. Contraception Handout: Handout covering contraception options
4
Control
Control group will receive educational handout on nutrition. Nutritional Handout: Handout covering nutrition
4
Total8

Baseline characteristics

CharacteristicControlTotalIntervention
Age, Continuous27.0 years
STANDARD_DEVIATION 5.1
27.1 years
STANDARD_DEVIATION 5.6
27.3 years
STANDARD_DEVIATION 6.9
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants6 Participants3 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
4 Participants5 Participants1 Participants
Sex: Female, Male
Female
4 Participants8 Participants4 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 40 / 4
other
Total, other adverse events
0 / 40 / 4
serious
Total, serious adverse events
0 / 40 / 4

Outcome results

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.

Time frame: 8 weeks postpartum

Population: Subjects who completed the 8 week survey

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
InterventionContraception UseReported YES to contraception use1 Participants
InterventionContraception UseReported NO to contraception use0 Participants
ControlContraception UseReported YES to contraception use1 Participants
ControlContraception UseReported NO to contraception use1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026