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Intrauterine Misoprostol Versus Rectal Misoprostol in Reducing Blood Loss During Cesarean Section

Primary Purpose

Hemorrhage, Postpartum

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemorrhage, Postpartum focused on measuring hemorrhage, misopristol, Cesarean section

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant women candidate for CS.
  • Full term singleton living pregnancies (> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan).
  • Spinal or epidural anesthesia for the CS.

Exclusion Criteria:

  • Maternal Anemia (hemoglobin <9 g%)
  • Maternal medical disorders (e.g. cardiac, renal, and hepatic diseases, or coagulopathies).
  • Fetal anomalies or IUGR (estimated fetal weight below the 5th centile)
  • Risk of obstetric hemorrhage (e.g. peripartum hemorrhage, abnormal placentation, previous history of uterine atony or postpartum hemorrhage).
  • Women attending for emergency CS.
  • More than 2 previous CS procedures.
  • Prolonged procedure (more than 2 hours from skin incision to skin closure).
  • History of prostaglandin allergy.

Sites / Locations

  • Faculty of medicine - Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

rectal misopristol

intrauterine misopristol

Arm Description

will receive 400 microgram misoprostol rectally preoperatively with urinary catheter insertion.

will receive 400 microgram misoprostol inserted intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta.

Outcomes

Primary Outcome Measures

estimated blood loss during and after CS
EBL= EBV x { (Preoperative hematocrit - Postoperative hematocrit) ÷ Postoperative hematocrit} Where EBV is estimated blood volume of the patient in mL (equals weight in kg × 85).

Secondary Outcome Measures

estimated blood loss during CS
The number of operative towels used - The difference of weight of operative towels (before and after cs) plus the amount of blood in suction unit (we will calculate 1 gram of weight difference equal to 1 ml blood loss).
Use of additional ecbolics denoting uterine atony
additional 5 IU intravenous bolus oxytocin and 1mL [0.2 mg] intramuscular ergometrine with or without 600 microgram rectal misoprostol postoperatively)
The occurrence of any maternal side effects (in both groups)
shivering, pyrexia >38C0, headache, nausea, vomiting with or without the need for antiemetic drugs
The occurrence of any fetal side effects (rectal group only)
APGAR at 1 and 5 minutes, NICU admission and neonatal death

Full Information

First Posted
October 25, 2018
Last Updated
March 17, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03723031
Brief Title
Intrauterine Misoprostol Versus Rectal Misoprostol in Reducing Blood Loss During Cesarean Section
Official Title
The Efficacy and Safety of Intrauterine Misoprostol Versus Rectal Misoprostol in Reducing Blood Loss During and After Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
April 15, 2020 (Anticipated)
Study Completion Date
May 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
98 pregnant women attending for CS will be randomized into 2 groups. Rectal misopristol group who will receive 400 microgram misoprostol rectally preoperatively with urinary catheter insertion and intrauterine misopristol group will receive 400 microgram misoprostol intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta. The estimated blood loss for each patient will be measured and data of both groups will be compared.
Detailed Description
The study we will include (98) pregnant women attending for cesarean delivery in the Kasr Elaini hospital (faculty of medicine - Cairo university).After signing informed written consent, all participants will be subjected to: Full medical history(including full obstetric history and current pregnancy history and the 1st day of last menstrual period), thorough clinical examination (general and full obstetric examination), obstetric ultrasonography (to confirm gestational age and the eligibility of the current pregnancy to participate in the study) and preoperative laboratory tests (including prothrombin time, prothrombin concentration, complete blood count, and liver and kidney function tests). Group allocation: On the day of the cesarean delivery, participants will be randomly assigned in a 1:1 ratio into two groups; group A (Rectal misoprostol) and group B (Intrauterine misoprostol). Randomization will be performed using computer-generated random numbers and only the participants will be masked to the group allocation. Group A (Rectal misoprostol - n=49) will receive 400 microgram misoprostol rectally preoperatively with urinary catheter insertion while group B (Intrauterine misoprostol n=49) will receive 400 microgram misoprostol (cytotec, Pfizer, G.D. Searle LLC) inserted intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta. Following the delivery of the baby, patients in both groups will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h). All cesarean sections will be done under spinal anesthesia by the following operative steps: pfannenstiel incision, transverse lower uterine segment incision, immediate cord clamping (< 30 seconds) and the placenta will be removed by controlled cord traction after its spontaneous separation, closure of uterus in 2 layers, closure of anterior abdominal wall in anatomical manner (adequate hemostasis will be ensured in all operative steps). The number and the difference of weight of operative towels (before and after CS) and amount of blood in suction unit will be recorded. The estimated blood loss for each patient will be measured and data of both groups will be compared. In group A, the time interval between rectal misoprostol insertion and fetal delivery will be recorded together with the neonatal outcome (APGAR at 1 and 5 minutes, NICU admission and neonatal death). Fluid monitoring will be performed through rate of infusion and urine output. A complete blood count test will be performed 12 hours after delivery. All patients will be followed up for 24 hours following the delivery as regard occurrence of primary postpartum hemorrhage, the need for blood transfusion, misoprostol-related side effects in the first 6 hours (i.e. shivering, pyrexia more than 38 degree Centigrate, headache, nausea, vomiting with or without the need for anti-emetic drugs).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Postpartum
Keywords
hemorrhage, misopristol, Cesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rectal misopristol
Arm Type
Active Comparator
Arm Description
will receive 400 microgram misoprostol rectally preoperatively with urinary catheter insertion.
Arm Title
intrauterine misopristol
Arm Type
Active Comparator
Arm Description
will receive 400 microgram misoprostol inserted intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta.
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
cytotec
Intervention Description
400 microgram (2 tablets) misoprostol ( cytotec, Pfizer, G.D. Searle LLC) inserted rectally (before CS) in rectal group or intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta in intrauterine group.
Primary Outcome Measure Information:
Title
estimated blood loss during and after CS
Description
EBL= EBV x { (Preoperative hematocrit - Postoperative hematocrit) ÷ Postoperative hematocrit} Where EBV is estimated blood volume of the patient in mL (equals weight in kg × 85).
Time Frame
within 12 hours after delivery
Secondary Outcome Measure Information:
Title
estimated blood loss during CS
Description
The number of operative towels used - The difference of weight of operative towels (before and after cs) plus the amount of blood in suction unit (we will calculate 1 gram of weight difference equal to 1 ml blood loss).
Time Frame
within the CS procedure
Title
Use of additional ecbolics denoting uterine atony
Description
additional 5 IU intravenous bolus oxytocin and 1mL [0.2 mg] intramuscular ergometrine with or without 600 microgram rectal misoprostol postoperatively)
Time Frame
within CS procedure
Title
The occurrence of any maternal side effects (in both groups)
Description
shivering, pyrexia >38C0, headache, nausea, vomiting with or without the need for antiemetic drugs
Time Frame
within 24 hours after the CS procedure
Title
The occurrence of any fetal side effects (rectal group only)
Description
APGAR at 1 and 5 minutes, NICU admission and neonatal death
Time Frame
within 24 hours after the CS procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant women candidate for CS. Full term singleton living pregnancies (> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan). Spinal or epidural anesthesia for the CS. Exclusion Criteria: Maternal Anemia (hemoglobin <9 g%) Maternal medical disorders (e.g. cardiac, renal, and hepatic diseases, or coagulopathies). Fetal anomalies or IUGR (estimated fetal weight below the 5th centile) Risk of obstetric hemorrhage (e.g. peripartum hemorrhage, abnormal placentation, previous history of uterine atony or postpartum hemorrhage). Women attending for emergency CS. More than 2 previous CS procedures. Prolonged procedure (more than 2 hours from skin incision to skin closure). History of prostaglandin allergy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
moutaz elsherbini, MD
Phone
(+2)01001588300
Email
mizosherbini@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mirna mohamed awad, MSc
Phone
(+2)01001401172
Email
mirnaawad91.ma@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
moutaz elsherbini, MD
Organizational Affiliation
Assistant professor of obstetrics and gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine - Cairo university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
moutaz el sherbini, MD
Phone
(+2)01001588300
Email
mizosherbini@yahoo.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33064852
Citation
El-Sherbini MM, Maged AM, Helal OM, Awad MO, El-Attar SA, Sadek JA, ElKomy R, Dawoud MA. A comparative study between preoperative rectal misoprostol and intraoperative intrauterine administration in the reduction of blood loss during and after cesarean delivery: A randomized controlled trial. Int J Gynaecol Obstet. 2021 Apr;153(1):113-118. doi: 10.1002/ijgo.13426. Epub 2020 Nov 6.
Results Reference
derived

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Intrauterine Misoprostol Versus Rectal Misoprostol in Reducing Blood Loss During Cesarean Section

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