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NCT03680339 Clinical Trial

The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS

Post Partum Hemorrhage Clinical Trial

Official title:
The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03680339
Other study ID # 42
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 2, 2018
Est. completion date January 28, 2019

Study information
Verified date June 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen Then we will compare between two groups regarding - Intaoperative blood loss - Risk of Postpartum hemorraghe in the first 24 hrs - HB pre and postoperative for all patients Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit

Description:

• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen Then we will compare between two groups regarding - Intaoperative blood loss - Risk of Postpartum hemorraghe in the first 24 hrs - HB pre and postoperative for all patients Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date January 28, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: women attending for elective CS. - Age between 20-35 years. - Normal placental site - Normal coagulation profile - Full term pregnancies(above 37 wks) - Medically free - Spinal anesthesia - Living baby - Average liquor by U/S Exclusion Criteria: - • Women attending for emergency CS - .age below 20 or above 35 - Abnormal placentation (Placenta previa,accrete,increta or percreta) - Women with coagulopathy - Preterm pregnancies (before 37 wks) - Medical disorder (Hypertension,Diabetes, Endocrinal disorder) - General anathesia - IUFD - Oligo or polyhydraminos by U/S

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• cesarean section
CS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers
Drug:
• Misoprostol
The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
• Oxytocin
10 IU of oxytocin with fetal delivery

Locations
Country Name City State
Egypt Kasr Alainy medical school Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary postpartum hemorrhage 24 hours after cesarean section
See also
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Completed NCT01866241 - Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage Phase 3
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Recruiting NCT04401839 - Amr Maneuver for Prevention of Postpartum Hemorrhage N/A
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Completed NCT01863706 - Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage Phase 1
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Terminated NCT04277962 - Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial N/A
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
Completed NCT03907605 - Anti-Mullerian Hormone (AMH) is a Marker for Ovarian Reserve. There Are Many Studies About AMH Changes in Ovarian Surgery, But Little is Known for Other Surgeries. We Seek to Investigate the Hormone Variations Before and After Uterine Artey Ligation for Postpartum Hemorrage (PPH)