Comparative Study Between Preoperative and Postoperative Rectal Misoprostol

October 14, 2023 updated by: Egymedicalpedia

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

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%

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of Medicine, Cairo University
        • Contact:
        • Principal Investigator:
          • Ayman Raslan, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Gestational age ( 37 to 41 weeks).
  2. Singleton healthy fetus.
  3. Scheduled for elective lower segment caesarean delivery under spinal anaesthesia.
  4. Body mass index of (25-30 Kg/m2).
  5. Normal coagulation profile.
  6. Normal amniotic fluid volume assessed by amniotic fluid index.

Exclusion Criteria:

  1. Maternal comorbidity: Hypertension; diabetes; heart, kidney, or liver disorders.
  2. Contraindication to use of misoprostol like known allergy to misoprostol or asthmatic patients.
  3. 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.
  4. 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.
  5. Antepartum hemorrhage ( placenta previa and placental abruption).
  6. Women who will undergo caesarean section because of failure of induction of labor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pre-operative and post-operative rectal misoprostol
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).
Drug: Misoprostol
All participants will be assigned for giving misoprostol rectally either preoperative or postoperative
Other Names:
  • Syntocinon
Active Comparator: Post-operative rectal misoprostol
64 participants who will receive rectal misoprostol post-operative only (600μg of rectal misoprostol after closure of the Cesarean Wound)).
Drug: Misoprostol
All participants will be assigned for giving misoprostol rectally either preoperative or postoperative
Other Names:
  • Syntocinon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss (defined as blood loss ≥500 cc)
Time Frame: First 2 hours from the starting of the operation
Outcome of the study will be measured in terms of assessment of Hemoglobin level
First 2 hours from the starting of the operation
Intraoperative blood loss (defined as blood loss ≥500 cc)
Time Frame: First 2 hours from the starting of the operation
Outcome of the study will be measured in terms of assessment of Hematocrit level
First 2 hours from the starting of the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours)
Time Frame: first 24 hours after C-Section]
Outcome of the study will be measured in terms of assessment of Hemoglobin level post operatively.
first 24 hours after C-Section]
Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours)
Time Frame: first 24 hours after C-Section]
Outcome of the study will be measured in terms of assessment of Hematocrit level post operatively.
first 24 hours after C-Section]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Egymedicalpedia

Investigators

  • Study Chair: Waleed El-Khayat, Professor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2023

Primary Completion (Estimated)

November 20, 2023

Study Completion (Estimated)

November 30, 2023

Study Registration Dates

First Submitted

September 15, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 14, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Martina Asaad

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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