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This is a prospective, randomized, controlled cohort study. This study will look at the effect of Ethinyl Estradiol 35mcg/Norethindrone 1mg and Ethinyl Estradiol 20 mcg/Norethindrone 1mg on postpartum depressive symptoms and sexual function scores when compared to a control group using no hormonal contraception. Depressive symptoms and sexual function will be measured using the Edinburgh Postnatal Depression Scale (EPDS), Arizona Sexual Experiences Scale (ASEX), and Brief Index of Sexual Functioning for Women (BISF-W). Participants will begin taking the medication at Week 3 postpartum, and these outcomes will be measured at baseline (0-1 day postpartum), Week 3, and Week 6-7. The investigators hypothesize that there will be an ethinyl estradiol dose related response in EPDS, ASEX, and BISF-W scores at Week 6-7, which would indicate a decrease in depressive symptoms and increase in sexual function in both of the oral contraceptive groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ethinyl Estradiol 35mcg/Noethindrone 1mg | Experimental | 21 day supply of Ethinyl Estradiol 35mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum |
|
| Ethinyl Estradiol 20mcg/Norethindrone 1mg | Experimental | 21 day supply of Ethinyl Estradiol 20mcg/Norethindrone 1mg will be taken beginning at Week 3 postpartum |
|
| No hormonal contraception | No Intervention | Women choosing copper IUD, spermicides, barrier methods, or sterilization (tubal ligation or partner vasectomy). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethinyl Estradiol 35mcg/Norethindrone 1mg | Drug |
| ||
| Ethinyl Estradiol 20mcg/Norethindrone 1mg |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Edinburgh Postnatal Depression Scale at baseline, 3 weeks postpartum and 6 weeks pospartum | Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum | |
| Change in Arizona Sexual Experiences Scale scores at baseline, 3 weeks postpartum, and 6-7 weeks postpartum | Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum | |
| Change in Brief Index of Sexual Functioning for Women scores at baseline, week 3 postpartum, and week 6-7 postpartum | Baseline (0-1 days postpartum), Week 3 Postpartum, Week 6-7 Postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Coitus | Time to first coitus during postpartum period | |
| Urine Pregnancy Test | Week 6-7 Postpartum |
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Inclusion Criteria:
Exclusion Criteria (Medication groups):
Exclusion Criteria (Control group):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly McDaniel, MS | Contact | mcdanik@evms.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sentara Norfolk General Hospital | Recruiting | Norfolk | Virginia | 23507 | United States |
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| Drug |
|
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009640 | Norethindrone |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009652 | Norpregnenes |
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