Sublingual Misoprostol in Reduction of Caesarean Blood Loss

NCT05532215 | Unknown DMC

• 1 other identifier: FMCY/O&G/SUMIROCBLOL/2022
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Caesarean delivery is inevitably associated with a higher amount of blood loss vis-à-vis primary postpartum haemorrhage, when compared to vaginal delivery. Oxytocin use in tropical developing countries for the reduction blood loss at caesarean section have been met with challenges of ineffectiveness due to poor transportation, inadequate storage and drug adulteration. Therefore, there is a need for an effective, temperature stable uterotonic with a lesser risk of adulteration. The study is aimed at evaluating the effectiveness and safety of adjunctive sublingual misoprostol in reducing intraoperative blood loss at caesarean section.

Conditions

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Estimated volume of intraoperative blood loss

  Intraoperative blood loss would be estimated by standard volumetric and gravimetric methods using standard calibrated suction bottles for the volumetric method and for the gravimetric method; wet weight of the abdominal mops, delivery mats, theatre drapes, theatre gowns and vaginal swabs will be gotten using the Mettler PB 153 weighing scale after its re-calibration. The total estimated intraoperative blood loss (T) will be measured by calculating the sum total of the weights of the blood soaked abdominal mops, vaginal gauzes, theatre drapes, theatre gowns and delivery mat (S) and subtracting the sum total of the dry weights of the used abdominal mops, vaginal gauzes, theatre drapes, theatre gowns and delivery mat (D) as shown in the equation: T = S - D. It will be assumed that 1 ml of blood weighs approximately 1 g

  Immediate postoperative period

Secondary Outcomes (4)

• Additional intraoperative oxytocic

  From intraoperative administration of the study intervention till 4 hours postoperative

• Postoperative blood transfusion

  From intraoperative administration of the study intervention till 48 hours postoperative

• Side effect profile

  From intraoperative administration of the study intervention till 4 hours postoperative

• Postoperative haematocrit level

  At 48 hours postoperative

Study Arms (2)

Misoprostol

EXPERIMENTAL

400 mcg of sublingual misoprostol as two 200 mcg misoprostol tablets at the point of starting the uterine incision at caesarean section, then bolus administration of 10 IU of intravenous oxytocin followed by an infusion of 20 IU of oxytocin in 500 ml of normal saline at a rate of twenty drops per minute to run over eight hours.

Drug: Misoprostol; Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Two sublingual placebo tablets similar to the misoprostol tablets at the point of starting the uterine incision at caesarean section, then bolus administration of 10 IU of intravenous oxytocin followed by an infusion of 20 IU of oxytocin in 500 ml of normal saline at a rate of twenty drops per minute to run over eight hours.

Drug: Oxytocin

Interventions

Misoprostol DRUG

The misoprostol tablets to be used in the study will be of the same brand and batch

Misoprostol

Oxytocin DRUG

The oxytocin ampoules to be used in the study will be of the same brand and batch

Misoprostol; Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women at term (37+0 weeks to 41+6 weeks gestational age) for elective or non-elective caesarean sections
• Pregnant women who have risk factor for primary postpartum haemorrhage
• Pregnant women who consent to participate in the study

You may not qualify if:

• Pregnant women who withhold consent to participate in the study
• Caesarean sections for dire emergencies (umbilical cord prolapse, suspected fetal distress and active antepartum haemorrhage)
• Previous caesarean sections or other uterine surgeries
• Pregnant women with no risk factor for primary postpartum haemorrhage
• Allergy to misoprostol use
• Known history of hepatic, renal and haematological disorders
• Caesarean section to be done under general anaesthesia
• Fever (temperature ≥ 37.5 degrees centigrade)
• Pre-operative anaemia (pre-operative haematocrit level \< 30 %)
• Pregnant women who are unconscious or have eclampsia

Sponsors & Collaborators

• OZORI EBIOGBO STANLEY: lead

Study Sites (1)

Federal Medical Centre Yenagoa

Yenagoa, Bayelsa State, 560231, Nigeria

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol; Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

• Stanley E Ozori

  Department of Obstetrics and Gynaecology, Federal Medical Centre, Yenagoa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanley E Ozori

CONTACT

+2348065876000; ozoriniseod@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A hospital's pharmacist/pharmacologist will manufacture the misoprostol tablets at doses of 200 mcg each as well as the placebo tablets (which will contain vitamin B complex excipient only). The misoprostol tablets and placebo tablets will be indistinguishable. Envelopes will be pre-packed, sealed and outwardly labelled by a hospital's pharmacist/pharmacologist who will take no further part in the study. Each pre-packed envelope will contain three 200 mcg misoprostol tablets for the misoprostol arm or three placebo tablets (which will contain vitamin B complex excipient only) for the placebo arm. The randomization list will be in the possession of a research assistant who will take no further part in the study after randomly allocating the participants to the study arms, till the end of the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 8, 2022
• Study Start: March 14, 2023
• Primary Completion: October 14, 2023
• Study Completion: November 14, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

NG (1)