Buccal Misoprostol Versus IV Oxytocin in Prevention of Postpartum Hemorrhage

NCT03676621 | Completed Phase 4

• 1 other identifier: BMISO
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall (hysterotomy). This definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• mean blood loss

  the amount of blood in towels and suction drain

  1 hour

Study Arms (2)

study group

EXPERIMENTAL

patients will receive buccal misoprostol

Drug: Misoprostol

control group

ACTIVE COMPARATOR

patients will receive intravenous oxytocin

Drug: Oxytocin

Interventions

Misoprostol DRUG

buccal tablets

study group

Oxytocin DRUG

intravenous drip

control group

Eligibility Criteria

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

You may qualify if:

• pregnant women
• term pregnancy
• singleton pregnancies
• booked for elective cesarean section

You may not qualify if:

• Medical disorders involving the heart,liver,kidney or brain
• Diabetes mellitus and hypertension
• Blood disorders (e.g. coagulopathies , thrombocytopenia )
• Patients requiring blood transfusion due to anemia
• Risk factors for uterine atony e.g. macrosomia , polyhydramnios ,multiple pregnancies
• Placenta previa or placental abruption
• Previous major obstetric haemorrhage (\>1000ml)in previous deliveries
• Known fibroid or adenomyosis
• Severe preeclampsia
• Uterine anomalies
• Women who received anticoagulant therapy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

Location

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 Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 19, 2018
• Study Start: November 1, 2018
• Primary Completion: August 30, 2021
• Study Completion: September 20, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

EG (1)