Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery

May 2, 2017 updated by: Mohamed Fathy, Ain Shams Maternity Hospital

Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate efficacy and safety of subligual misoprostol in reducing blood loss during cesarean section , a randomized double blinded prospective controlled trial conducted at Ain Shams maternity hospital . 158 women who fulfilled the inclusion criteria enrolled in this study .the patients randomized into two groups one of them will receive sublingual misoprostol 400 micrograms ( misotac )and the other will receive placebo( Ranitak ),all patients will subjected to history,physical examination,and investigations.preparation of patients (preload and antibiotics )according to hospital protocol.All C.S will be perfomed using spinal anaesthesia ,pfannenstiel incision of the skin ,open of abdomen in layers ,at cord clamping the patients will receive the medication sublingual and 20IU of oxytocin intravenous infusion simultaneous by the anesthesiologist,then close in anatomical layers.blood loss during C.S will be calculated following placental delivery to the end of surgery,and from the end of the operation to 6h after birth.the need for additional uterotonics agents,blood transfusion and adverse effects of the study drug will be recorded.

Study Type

Interventional

Enrollment (Anticipated)

158

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

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

19 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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 )

Exclusion Criteria:

  • 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

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Misoprostol oral tablets
79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping
Drug: Misoprostol Oral Tablet
at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually
Other Names:
  • Misotac
PLACEBO_COMPARATOR: Ranitidine oral tablets
79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping
Drug: Ranitidine Oral Tablet
at cord clamping the patient will recieve ranitidine sublingually
Other Names:
  • Ranitak

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss during cesarean sections
Time Frame: through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal bleeding
Time Frame: through study completion, an average of 1 year
Calculation of the amount of vaginal bleeding according to the number of soaked pads used after cesarea section for the 1st 6 hrs. Each soaked pad equal 50 cc
through study completion, an average of 1 year
Change in blood pressure and pulse
Time Frame: through study completion, an average of 1 year
Change in blood pressure and pulse before and after the cesarean section
through study completion, an average of 1 year
Blood loss after 24 hr.
Time Frame: through study completion, an average of 1 year
The allowable blood loss (ABL) =[ estimated blood volume ( EBV ) x (intial hematocrit (HI ) - final hematocrit (HF) ] / HI ( initial hematocrit)
through study completion, an average of 1 year
Need for additional uterotonic agent
Time Frame: through study completion, an average of 1 year
Need for additional uterotonic agent e.g oxytocin - methyl ergotamine
through study completion, an average of 1 year
Need for blood transfusion
Time Frame: through study completion, an average of 1 year
number of patients receiving blood transfusion
through study completion, an average of 1 year
Need for surgical measures to stop bleeding
Time Frame: through study completion, an average of 1 year
Need for surgical measures to stop bleeding e.g uterine artery ligation , B-lynch sutures or Hysterectomy
through study completion, an average of 1 year
Side effects of misoprostol
Time Frame: through study completion, an average of 1 year
Nausea, Vomiting or Diarrhea
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Study Director: Amr H YEHIA, MD,MRCOG, Ain Shams University-Maternity Hospital

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)

July 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

May 1, 2017

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (ACTUAL)

May 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 2, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MFathy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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