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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants.
In the United States, depot medroxyprogesterone acetate (DMPA) is given to women after delivery and before hospital discharge with the belief that women who delay starting DMPA may be more likely to become pregnant when they are not yet ready to be pregnant and that giving DMPA before discharge has little to no negative effect on breastfeeding. Administering DMPA to breastfeeding women has not been widely questioned because the limited existing studies do not show any adverse impact of DMPA on breastfeeding. However, these studies used inappropriate control groups and did not control for prior lactation experience.
The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants. The investigators will also look at rates of use of highly effective contraception (defined as DMPA, intrauterine device, implant, sterilization, or lactational amenorrhea) and postpartum depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMPA postpartum | Active Comparator | Depot medroxyprogesterone acetate postpartum |
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| DMPA at 4-6 weeks after delivery | Active Comparator | Depot medroxyprogesterone acetate at 4-6 weeks after delivery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depot medroxyprogesterone acetate | Drug | Postpartum administration of DMPA (prior to hospital discharge) |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA | Any breastfeeding at specific time intervals postpartum | 2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA | Use of DMPA, IUD, implant, or sterilization | 6 months |
| Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Coordinator | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Family Planning Research, Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
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Since participants could be recruited antepartum but may have changed their mind about breastfeeding or DMPA use post-partum, eligibility criteria were re-assessed postpartum, prior to randomization, thus the number of women enrolled in the study (184) does not equal the number of women randomized (157).
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| ID | Title | Description |
|---|---|---|
| FG000 | DMPA Postpartum | Depot medroxyprogesterone acetate postpartum Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge) |
| FG001 | DMPA at 4-6 Weeks After Delivery |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| 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 | Oct 16, 2014 |
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| Depot medroxyprogesterone acetate | Drug | Delayed administration of DMPA (4-6 weeks postpartum) |
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Edinburgh Postnatal Depression Scale (EPDS) score after postpartum or delayed initiation of DMPA: minimum possible score 0, maximum possible score 30; score of 12 or greater is a positive screen for postpartum depression |
| 8 weeks postpartum |
| Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA | Exclusive breastfeeding at specific time intervals postpartum | 2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum |
Depot medroxyprogesterone acetate at 4-6 weeks after delivery
Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum)
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | DMPA Postpartum | Depot medroxyprogesterone acetate postpartum Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge) |
| BG001 | DMPA at 4-6 Weeks After Delivery | Depot medroxyprogesterone acetate at 4-6 weeks after delivery Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA | Any breastfeeding at specific time intervals postpartum | 1 ppt withdrawn postrandomization due to enrollment violation (did not meet eligibility criteria) | Posted | Count of Participants | Participants | 2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum |
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| Secondary | Rates of Use of Highly Effective Contraception (Defined as DMPA, IUD, Implant, Sterilization, or Lactational Amenorrhea) After Postpartum or Delayed Initiation of DMPA | Use of DMPA, IUD, implant, or sterilization | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA | Edinburgh Postnatal Depression Scale (EPDS) score after postpartum or delayed initiation of DMPA: minimum possible score 0, maximum possible score 30; score of 12 or greater is a positive screen for postpartum depression | Excludes 14 participants with a missed call at 8 weeks postpartum | Posted | Median | Inter-Quartile Range | scores on a scale | 8 weeks postpartum |
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| Secondary | Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA | Exclusive breastfeeding at specific time intervals postpartum | Two participants withdrew during follow-up | Posted | Count of Participants | Participants | 2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum |
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6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DMPA Postpartum | Depot medroxyprogesterone acetate postpartum Depot medroxyprogesterone acetate: Postpartum administration of DMPA (prior to hospital discharge) | 0 | 79 | 0 | 79 | 0 | 79 |
| EG001 | DMPA at 4-6 Weeks After Delivery | Depot medroxyprogesterone acetate at 4-6 weeks after delivery Depot medroxyprogesterone acetate: Delayed administration of DMPA (4-6 weeks postpartum) | 0 | 78 | 0 | 78 | 0 | 78 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Center for Family Planning Research | 412-641-5496 | fpr@upmc.edu |
| Feb 14, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C050795 | N,N-dimethyl-4-anisidine |
| D017258 | Medroxyprogesterone Acetate |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Male |
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| Black |
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| Other |
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| Hispanic |
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| Formula only |
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| Missed call |
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| 4 weeks postpartum |
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| 6 weeks postpartum |
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| 8 weeks postpartum |
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| 12 weeks postpartum |
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| 16 weeks postpartum |
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| 20 weeks postpartum |
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| 24 weeks postpartum |
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| 28 weeks postpartum |
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| Any formula |
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| Missed call |
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| Any formula |
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| Missed call |
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| Any formula |
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| Missed call |
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| Any formula |
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| Missed call |
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| Any formula |
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| Missed call |
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| Any formula |
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| Missed call |
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| Any formula |
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| Missed call |
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| Any formula |
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| Missed call |
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