Comparative Study Between Preoperative and Postoperative Rectal Misoprostol

NCT06049160 | Completed DMC

• 1 other identifier: Martina Asaad
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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%

Conditions

Blood Loss, Surgical; Blood Loss, Postoperative

Keywords

blood loss; Cesarean Section; Oxytocin; Rectal Misoprostol

Outcome Measures

Primary Outcomes (2)

• Intraoperative blood loss (defined as blood loss ≥500 cc)

  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)

  Outcome of the study will be measured in terms of assessment of Hematocrit level

  First 2 hours from the starting of the operation

Secondary Outcomes (2)

• Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours)

  first 24 hours after C-Section]

• Occurrence of primary postpartum hemorrhage ( defined as excessive blood loss as 1000cc during first 24 hours)

  first 24 hours after C-Section]

Study Arms (2)

Pre-operative and post-operative rectal misoprostol

ACTIVE COMPARATOR

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

Post-operative rectal misoprostol

ACTIVE COMPARATOR

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

Drug: Misoprostol

Interventions

Misoprostol DRUG

All participants will be assigned for giving misoprostol rectally either preoperative or postoperative

Also known as: Syntocinon

Post-operative rectal misoprostol; Pre-operative and post-operative rectal misoprostol

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Faculty of medicine, Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Blood Loss, Surgical; Postoperative Hemorrhage; Hemorrhage

Interventions

Misoprostol; Oxytocin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Waleed El-Khayat, Professor

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: August 31, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 30, 2023
• Last Updated: August 20, 2024

Record last verified: 2023-10

Locations

EG (1)