Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

NCT03140033 | Unknown Phase 2 DMC

• 1 other identifier: MFathy
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial

Conditions

Hemorrhage Postpartum

Outcome Measures

Primary Outcomes (1)

• Blood loss during cesarean sections

  Blood loss will be estimated by the anesthesiologist Using soaked towels and suction set after delivery of placenta

  through study completion, an average of 1 year

Secondary Outcomes (7)

• Vaginal bleeding

  through study completion, an average of 1 year

• Change in blood pressure and pulse

  through study completion, an average of 1 year

• Blood loss after 24 hr.

  through study completion, an average of 1 year

• Need for additional uterotonic agent

  through study completion, an average of 1 year

• Need for blood transfusion

  through study completion, an average of 1 year

Study Arms (2)

Misoprostol oral tablets

ACTIVE COMPARATOR

79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping

Drug: Misoprostol Oral Tablet

Ranitidine oral tablets

PLACEBO COMPARATOR

79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping

Drug: Ranitidine Oral Tablet

Interventions

Misoprostol Oral Tablet DRUG

at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually

Also known as: Misotac

Misoprostol oral tablets

Ranitidine Oral Tablet DRUG

at cord clamping the patient will recieve ranitidine sublingually

Also known as: Ranitak

Ranitidine oral tablets

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• singleton pregnancies
• women booked for elective C.S
• full term pregnancies
• primi gravida or previous one delivery ( either by spontaneous vaginal delivery or C.S )

You may not qualify if:

• blood disorders
• multiple pregnancy
• placenta previa
• polyhydramnios
• marked maternal anemia
• contraindications to prostaglandin e.g history of asthma , allergy to misoprostol
• previous 2 or more C.S

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain shams maternity hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol; Ranitidine

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; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Amr H YEHIA, MD,MRCOG

  Ain Shams University-Maternity Hospital

  STUDY DIRECTOR

Central Study Contacts

Mohamed H Fathy, M.B.B.Ch

CONTACT

00201099984100; Mohamedfathy31085@gmail.com

Amr YEHIA, MD,MRCOG

CONTACT

00201227900014; am_helmy77@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of obstetrics and gynecology

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 4, 2017
• Study Start: July 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)