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| Name | Class |
|---|---|
| Sponsor GmbH | OTHER |
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To determine if placental cord drainage decreases the blood loss after spontaneous vaginal delivery
Postpartum hemorrhage complicates 3% of pregnancies in the United States and is a leading cause of maternal morbidity and mortality. ACOG defines PPH as cumulative blood loss greater than 1000cc; however a blood loss >500cc should be considered abnormal. Primary PPH occurs in the first 24 hours and is largely secondary to uterine agony. ACOG as well as the WHO recommend active management of the third stage of labor to prevent PPH. This includes oxytocin administration, uterine massage, and gentle cord traction. Placental cord drainage (PCD) is the unclamping of the umbilical cord to allow for drainage of the blood from the placenta. It is another technique used to shorten the third stage of labor; however, it has not been well studied
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placenta Blood Drained | Experimental | Immediately after delayed cord clamping and cutting of the umbilical cord, the cord will be unclamped and blood with be drained until cessation of flow. |
|
| Placenta Blood Not Drained | Active Comparator | This is the control group. The cord will not be unclamped. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placental Blood Drainage | Procedure | Immediately after vaginal delivery following delayed cord clamping and cutting of the cord, the cord will be unclamped and blood will be drained from the placenta until cessation of flow. |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Blood Loss | Total Volume in Underbuttocks Drape - Initial Volume in Drape (amniotic fluid etc) + blood in laparotomy sponges | Through delivery completion, on average 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Third Stage of Labor | After neonatal delivery to delivery of the placenta | On average 30 minutes |
| Retained Placenta | Placenta not delivered > 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Schorge, MD, FACS | Regional One Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional One Health | Memphis | Tennessee | 38103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28937571 | Background | Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351. | |
| 40455892 | Background | WHO recommendations on maternal health: guidelines approved by the WHO Guidelines Review Committee [Internet]. Geneva: World Health Organization; 2017. Available from http://www.ncbi.nlm.nih.gov/books/NBK615100/ |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Placenta Blood Drained Placenta Blood Not Drained
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| Placenta Blood Not Drained | Procedure | Placenta Blood Not Drained |
|
| 30 minutes after delivery |
| Postpartum Hemorrhage | Blood Loss Greater than 1000cc | 30 minutes to 1 hour after delivery |
| Blood Loss > 500 cc | Greater than average postpartum blood loss | 30 minutes to 1 hour after delivery |
| Need for Blood Transfusion | In event of HgB <7 or active bleeding | Up to 24 hours postpartum |
| Percent Drop in HgB and Hct | Lab draw following delivery | Up to 48 hours following delivery |
| Additional Uterotonic Administration | Medications administered to stop postpartum bleeding | 30 minutes to 1 hour following delivery |
| Endometritis | Infection of myometrium of uterus | Up to 12 weeks following delivery |
| 27651611 | Result | Roy P, Sujatha MS, Bhandiwad A, Biswas B, Chatterjee A. Placental Blood Drainage as a Part of Active Management of Third Stage of Labour After Spontaneous Vaginal Delivery. J Obstet Gynaecol India. 2016 Oct;66(Suppl 1):242-5. doi: 10.1007/s13224-016-0857-3. Epub 2016 Mar 12. |
| 28765609 | Result | Wu HL, Chen XW, Wang P, Wang QM. Effects of placental cord drainage in the third stage of labour: A meta-analysis. Sci Rep. 2017 Aug 1;7(1):7067. doi: 10.1038/s41598-017-07722-7. |
| 29718920 | Result | Vasconcelos FB, Katz L, Coutinho I, Lins VL, de Amorim MM. Placental cord drainage in the third stage of labor: Randomized clinical trial. PLoS One. 2018 May 2;13(5):e0195650. doi: 10.1371/journal.pone.0195650. eCollection 2018. |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |