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NCT03148574 Clinical Trial

Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery

Post Partum Hemorrhage Clinical Trial

Official title:
Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery to Reduce Intraoperative and Postoperative Blood Loss: A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03148574
Other study ID # IUM
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 2, 2017
Est. completion date December 15, 2019

Study information
Verified date April 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Bleeding is still the major cause of mortality and morbidity in postpartum period. World health organization has reported 585000 deaths for pregnancy each year. Twenty five percent of cases die from post-partum bleeding. Mean amount of blood lost is 500 ml during normal vaginal delivery, 1000 ml in cesarean section, and 3500 ml during cesarean section with emergency hysterectomy

Recruitment information / eligibility
Status Completed
Enrollment 240
Est. completion date December 15, 2019
Est. primary completion date September 15, 2019
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: 1-Uncomplicated pregnancy, 2-Had no hypersensitivity or contraindications to prostaglandins. 3-Had no history of coagulopathy. 4-Accepting to participate in the study. Exclusion Criteria: \1-women with anemia (Haemoglobin <8 gram ). 2 placental abnormality (e.g placenta previa,placenta abruption ) 3. History of complications at previous pregnancy especially postpartum hemorrhage. 4- Maternal hypertension , current or previous history of heart disease ,liver ,Renal disorders or known coagulopathy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Misoprostol
intrauterine tablets
• Oxytocin
intravenous

Locations
Country Name City State
Egypt Assiut Faculty of Medicine Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary amount of intraoperative blood loss 30 minutes
See also
  Status Clinical Trial Phase
Completed NCT03680339 - The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS Phase 4
Completed NCT03693599 - Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean Phase 4
Completed NCT03707132 - Tourniquet Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta
Recruiting NCT02306733 - Ergometrine Versus Oxytocin in the Management of Atonic Post-partum Haemorrhage (PPH) in Women Delivered Vaginally Phase 3
Completed NCT01866241 - Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage Phase 3
Not yet recruiting NCT01236482 - Oxytocin in Cesarean Delivery Phase 4
Completed NCT03784794 - Patient Blood Management for Massive Obstetric Hemorrhage N/A
Recruiting NCT04401839 - Amr Maneuver for Prevention of Postpartum Hemorrhage N/A
Not yet recruiting NCT06219538 - DAISY Uterine Drain Device Evaluation N/A
Completed NCT01863706 - Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage Phase 1
Not yet recruiting NCT05488457 - Oxytocin Pharmacokinetics and Pharmacodynamics Phase 2
Terminated NCT04277962 - Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial N/A
Completed NCT04723979 - NovoSeven® in Severe Postpartum Haemorrhage - Experiences From UK, DK, FR, NL
Completed NCT03570723 - Glove-loaded Foley's Catheter Tamponade for Cesarean Section for Placenta Previa N/A
Completed NCT03117647 - Mansoura-VV Uterine Compression Suture for Primary Atonic Postpartum Hemorrhage N/A
Active, not recruiting NCT03069859 - Use of TXA to Prevent Postpartum Hemorrhage Phase 2
Not yet recruiting NCT03891082 - A Comparative Study Between Bakri Balloon and B Lynch Suture Used to Control Primary Postpartum Hemorrhage After Cesarean Section N/A
Not yet recruiting NCT03463070 - Misoprostol Before and After Cesarean Section Phase 3
Recruiting NCT05532215 - Sublingual Misoprostol in Reduction of Caesarean Blood Loss N/A
Not yet recruiting NCT06255496 - QStat Cartridge in Obstetric Patients