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Comparative Study Between Preoperative and Postoperative Rectal Misoprostol

Primary Purpose

Blood Loss, Surgical, Blood Loss, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss, Surgical focused on measuring blood loss, Cesarean Section, Oxytocin, Rectal Misoprostol

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Gestational age ( 37 to 41 weeks). Singleton healthy fetus. Scheduled for elective lower segment caesarean delivery under spinal anaesthesia. Body mass index of (25-30 Kg/m2). Normal coagulation profile. Normal amniotic fluid volume assessed by amniotic fluid index. Exclusion Criteria: Maternal comorbidity: Hypertension; diabetes; heart, kidney, or liver disorders. Contraindication to use of misoprostol like known allergy to misoprostol or asthmatic patients. Women who had undergone any previous uterine surgery such as myomectomy because it is considered upper uterine segment operation with more destruction in myometrium but caesarean section is a lower segment uterine operation with minimal destruction in myometrium. Women at higher risk of intraoperative blood loss or PPH, such as those with hemoglobin levels less than 9 g/dl, history of PPH, or uterine fibroids. Antepartum hemorrhage ( placenta previa and placental abruption). Women who will undergo caesarean section because of failure of induction of labor.

Sites / Locations

  • Faculty of medicine, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pre-operative and post-operative rectal misoprostol

Post-operative rectal misoprostol

Arm Description

64 participants who will receive combined pre-operative and post-operative rectal misoprostol (400μg rectal misoprostol during urinary catheter insertion just after spinal anesthesia plus 200μg after abdominal closure).

64 participants who will receive rectal misoprostol post-operative only (600μg of rectal misoprostol after closure of the Cesarean Wound)).

Outcomes

Primary Outcome Measures

Intraoperative blood loss (defined as blood loss ≥500 cc)
Outcome of the study will be measured in terms of assessment of Hemoglobin level
Intraoperative blood loss (defined as blood loss ≥500 cc)
Outcome of the study will be measured in terms of assessment of Hematocrit level

Secondary Outcome Measures

Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours)
Outcome of the study will be measured in terms of assessment of Hemoglobin level post operatively.
Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours)
Outcome of the study will be measured in terms of assessment of Hematocrit level post operatively.

Full Information

First Posted
September 15, 2023
Last Updated
October 14, 2023
Sponsor
Egymedicalpedia
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1. Study Identification

Unique Protocol Identification Number
NCT06049160
Brief Title
Comparative Study Between Preoperative and Postoperative Rectal Misoprostol
Official Title
A Comparative Study Between Preoperative and Postoperative Rectal Misoprostol in the Reduction of Blood Loss During and After Elective Cesarean Section : A Double Blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cesarean delivery (CD) is the most common major surgical procedure undergone by women around the world. Over the past two decades, there has been a witnessed increase in rates of caesarean deliveries, which continues to rise, achieving 30% in resource-rich countries and exceeding 60% in resource-limited countries. According to a Lancet report 2014, Egypt is one of the countries with the highest rates of caesarean delivery, in which the rate had reached 55.5%. The rate is almost double to three times the ideal rate of 10%-15%
Detailed Description
In resource-limited countries, postpartum hemorrhage (PPH) remains the leading cause of maternal mortality. The increased rates of caesarean delivery have been incriminated as the primary cause behind the rise in PPH. PPH after a caesarean delivery has been defined as blood loss over 1000 ml. The estimated prevalence rate of PPH is in the range of 0.6%-6.4%. Increased blood loss after CD reflects several factors, including surgical incisions, lack of background uterine contraction, and manual removal of placenta rather than waiting for its spontaneous separation after placental bed retraction. Minimizing blood loss during delivery is an important preventive health objective aimed at reducing postpartum anemia and related morbidity . It has been reported that the prevalence of postpartum anemia in low-income countries is approximately 50%-80%. The major cause of postpartum anemia is blood loss at delivery, especially in presence of prepartum anemia. Postpartum anemia constitutes an appreciable health problem among women of reproductive age and is associated with reduced quality of life, impaired cognition, emotional instability, and depression. Oxytocin is routinely used by obstetricians to prevent excessive blood loss during CD. Oxytocin is the uterotonic of choice in obstetric medicine. Both the Royal College of Obstetricians and Gynecologists and the American College of Obstetricians and Gynecologists currently recommend the routine use of oxytocin (5 IU bolus dose or infusion, respectively) after the delivery of the infant as a prophylactic measure against PPH. However, oxytociin is a dangerous drug with serious adverse effects such as hypotension, tachyc ardiaand myocardial ischemia . Misoprostol is a prostaglandin E1 analogue that effectively prevents and treats PPH owin g to its uterotonic properties. It can be used through different routes: oral; sublingual; bucc al; rectal; and intrauterine with similar efficacy to oxytocin in reducing blood loss. The benefits of misoprostol (cervical dilation and uterine contractions) and its adverse effects (nausea, vomiting, diarrhea, fever, and chills) are dose dependent . Misoprostol is affordable and widely available, easily administered via multiple routes ( vaginal, rectal, sublingual, and oral), and has a good safety profile if properly administered and monitored, all of which make it the standard treatment option for PPH in low-resource settings. Misoprostol administered vaginally is affected by vaginal acidity and the bacterial micro-environment. Sublingual route has the highest peak concentration; however, it is also associated with the highest incidence of adverse effects due to high peak concentrati on. Rectally administered misoprostol is associated with slower absorption, lower peak c oncentration levels, and reduced adverse effects compared with the oral and sublingua l routes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical, Blood Loss, Postoperative
Keywords
blood loss, Cesarean Section, Oxytocin, Rectal Misoprostol

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-operative and post-operative rectal misoprostol
Arm Type
Active Comparator
Arm Description
64 participants who will receive combined pre-operative and post-operative rectal misoprostol (400μg rectal misoprostol during urinary catheter insertion just after spinal anesthesia plus 200μg after abdominal closure).
Arm Title
Post-operative rectal misoprostol
Arm Type
Active Comparator
Arm Description
64 participants who will receive rectal misoprostol post-operative only (600μg of rectal misoprostol after closure of the Cesarean Wound)).
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Syntocinon
Intervention Description
All participants will be assigned for giving misoprostol rectally either preoperative or postoperative
Primary Outcome Measure Information:
Title
Intraoperative blood loss (defined as blood loss ≥500 cc)
Description
Outcome of the study will be measured in terms of assessment of Hemoglobin level
Time Frame
First 2 hours from the starting of the operation
Title
Intraoperative blood loss (defined as blood loss ≥500 cc)
Description
Outcome of the study will be measured in terms of assessment of Hematocrit level
Time Frame
First 2 hours from the starting of the operation
Secondary Outcome Measure Information:
Title
Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours)
Description
Outcome of the study will be measured in terms of assessment of Hemoglobin level post operatively.
Time Frame
first 24 hours after C-Section]
Title
Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours)
Description
Outcome of the study will be measured in terms of assessment of Hematocrit level post operatively.
Time Frame
first 24 hours after C-Section]

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age ( 37 to 41 weeks). Singleton healthy fetus. Scheduled for elective lower segment caesarean delivery under spinal anaesthesia. Body mass index of (25-30 Kg/m2). Normal coagulation profile. Normal amniotic fluid volume assessed by amniotic fluid index. Exclusion Criteria: Maternal comorbidity: Hypertension; diabetes; heart, kidney, or liver disorders. Contraindication to use of misoprostol like known allergy to misoprostol or asthmatic patients. Women who had undergone any previous uterine surgery such as myomectomy because it is considered upper uterine segment operation with more destruction in myometrium but caesarean section is a lower segment uterine operation with minimal destruction in myometrium. Women at higher risk of intraoperative blood loss or PPH, such as those with hemoglobin levels less than 9 g/dl, history of PPH, or uterine fibroids. Antepartum hemorrhage ( placenta previa and placental abruption). Women who will undergo caesarean section because of failure of induction of labor.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Youssef Asaad, MSC
Phone
01220156636
Email
martinayoussef93@icloud.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Ahmed Ismail, Lecturer
Phone
01003457468
Email
Dr_mahmoud_ahmed2015@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed El-Khayat, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Chair
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
Waleed El-Khayat, Professor
Phone
01005135542
Email
waleedelkhayat@kasralainy.edu.eg
First Name & Middle Initial & Last Name & Degree
Ayman Raslan, Professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparative Study Between Preoperative and Postoperative Rectal Misoprostol

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