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NCT01931423 Clinical Trial

The Influence of Placental Drainage of Management of the Third Stage of Labor:a Randomized Controlled Study

Postpartum Haemorrhage Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01931423
Other study ID # Asicioglu-06
Secondary ID
Status Completed
Phase N/A
First received August 26, 2013
Last updated March 7, 2014
Start date November 2013
Est. completion date March 2014

Study information
Verified date November 2013
Source Istanbul Bakirkoy Maternity and Children Diseases Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial Summary

To determine whether early placental drainage plus cord traction reduces the incidences of manual removal and blood loss, and to determine the risk factors associated with blood loss after delivery.

Recruitment information / eligibility
Status Completed
Enrollment 485
Est. completion date March 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 44 Years
Eligibility Inclusion Criteria:

1. greater than 37 gestational weeks

2. single pregnancy

3. vaginal delivery

4. estimated fetal weight 2500-4500 gr.

Exclusion Criteria:

1. PPROM

2. 37 or lower gestational week

3. multiple pregnancy

4. grand multiparity (greater than 5)

5. coagulation defects (HELLP, ablation placenta, previa, pre-eclampsia)

6. a history of any bleeding during pregnancy

7. caesarean delivery or any uterine scar

8. a history of postpartum haemorrhage

9. hydramnios

10. known uterine anomalies

11. suspected abnormal placentation (accreta, increta, or percreta)

12. prepartum hemoglobin concentration less than 8 g/dL

13. history of anticoagulant drugs and prolongation of the first stage of labor longer than 15 hours

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Placental cord drainage

Locations
Country Name City State
Turkey Osman Asicioglu Istanbul SiSLI

Sponsors (1)
Lead Sponsor Collaborator
Istanbul Bakirkoy Maternity and Children Diseases Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary postpartum blood loss 24 hours Yes
See also
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Completed NCT00499005 - Carbetocin Versus Syntometrine for the Third Stage of Labour Phase 4
Completed NCT01485562 - Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births N/A
Completed NCT01359878 - Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial Phase 2/Phase 3
Completed NCT00872469 - World Maternal Antifibrinolytic Trial Phase 3
Completed NCT02704780 - Two Different Regimens of Misoprostol in Retained Placenta Phase 2
Not yet recruiting NCT02396303 - Carbetocin Versus Oxytocin in Caesarean Section for the Control of Postpartum Haemorrhage Phase 0
Completed NCT01931410 - The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial Phase 4
Completed NCT01895218 - Treatment of Women After Postpartum Haemorrhage Phase 3
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Withdrawn NCT01910675 - PCC and Fibrinogen Compared With FFP in PPH Phase 4
Completed NCT02562300 - Uterotonics Using to Reduce Bleeding at Cesarean Section Phase 2
Completed NCT01044082 - Prevention of Post-partum Haemorrhage N/A
Completed NCT01116050 - Intrarectal Misoprostol in Postpartum Haemorrhage Phase 3
Completed NCT02149472 - Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage
Recruiting NCT02492087 - Topical Tranexamic Acid in Caesarean Section Phase 3
Completed NCT02468310 - Evaluating the Effects of SMS Text Messaging Support System Among Frontline Health Workers in Ghana N/A
Recruiting NCT02136719 - Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery N/A