Not provided
Not provided
Not provided
Not provided
Not provided
Insufficient research staff to recruit and complete study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intervention group will receive educational handout on contraception. |
|
| Control | Experimental | Control group will receive educational handout on nutrition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contraception Handout | Other | Handout covering contraception options |
| |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
This study will recruit women who are 24-28 weeks gestational age.
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christina DeAngelis, MD | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Health Center | Hershey | Pennsylvania | 17033 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Intervention group will receive educational handout on contraception. Contraception Handout: Handout covering contraception options |
| FG001 | Control | Control group will receive educational handout on nutrition. Nutritional Handout: Handout covering nutrition |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Intervention group will receive educational handout on contraception. Contraception Handout: Handout covering contraception options |
| BG001 | Control | Control group will receive educational handout on nutrition. Nutritional Handout: Handout covering nutrition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Subjects who completed the 8 week survey | Posted | Count of Participants | Participants | 8 weeks postpartum |
|
8 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Intervention group will receive educational handout on contraception. Contraception Handout: Handout covering contraception options |
Not provided
Not provided
Termination of the study leading to small number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina DeAngelis | Penn State Health, Milton S. Hershey Medical Center | 717-531-5994 | 3763 | cdeangelis2@pennstatehealth.psu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 6, 2019 | Jun 7, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 2, 2020 | Jun 7, 2022 | ICF_001.pdf |
Not provided
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.
Not provided
Not provided
Not provided
| Nutritional Handout |
| Other |
Handout covering nutrition |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Control | Control group will receive educational handout on nutrition. Nutritional Handout: Handout covering nutrition | 0 | 4 | 0 | 4 | 0 | 4 |
Not provided
Not provided
Not provided