Two Different Regimens of Misoprostol in Retained Placenta

February 21, 2019 updated by: Shahla Alalaf, Hawler Medical University

Umbilical Vein Injection of 800µg Misoprostol Versus 400 µg Misoprostol in the Treatment of Retained Placenta: A Multicenter, Randomized Double Blind Controlled Trial

This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for the treatment of retained placenta to reduce the need of manual removal of placenta under general anaesthesia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The third stage of labor may be complicated by retained placenta, which may cause severe bleeding and infection, with a potentially fatal outcome. Manual removal of placenta is the current standard of management of retained placenta which usually requires general or regional anaesthesia at a hospital and it is an invasive procedure that may lead to bleeding, trauma and infection. Intraumbilical injection of uterotonic agent( misoprostol) is an easy, non invasive procedure. A randomized clinical trial are required to determine the difference between two doses of misoprostol 400 versus 800 micro gram for management of retained placenta

Study Type

Interventional

Enrollment (Actual)

509

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

  • Iraq
    • Kurdistan Region
      • Erbil, Kurdistan Region, Iraq, 44001
        • Hawler Medical University

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

15 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women with a singleton pregnancy, delivered vaginally
  • 28 weeks of gestation and more,
  • had a prolonged third stage of labor (more than 30 minutes) despite active management,
  • Haemodynamically stable and accept to participate in the trial

Exclusion Criteria:

  • multiple pregnancies,
  • previous caesarean delivery,
  • haemodynamically instability, severe anaemia (haemoglobin concentration <8 g/dL),
  • chorioamnionitis
  • Refused to participate in the trial

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: 400 Microgram Misoprostol
Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group
Drug: Misoprostol
2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women
Other Names:
  • Cytotic
ACTIVE_COMPARATOR: 800 Microgram Misoprostol
Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group
Drug: Misoprostol
2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women
Other Names:
  • Cytotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol
Time Frame: up to 30 minutes after intraumbilical injection
complete delivery of placenta after injection of intraumbilical misoprostol
up to 30 minutes after intraumbilical injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The amount of blood loss vaginally in both groups
Time Frame: up to 30 minutes after injection of placenta
To estimate the amount of vaginal blood loss from time of injection of the the interventional drug and till the delivery of the placenta
up to 30 minutes after injection of placenta
The time of delivery of placenta in both groups
Time Frame: up to 30 minutes after delivery of the placenta
the time interval estimation from the injection to complete delivery of the placenta
up to 30 minutes after delivery of the placenta
side effects of misoprostol
Time Frame: up to 24 hours after delivery of placenta
Any side effects related to misoprostol after the injection (Fever, severing , diarrhea)
up to 24 hours after delivery of placenta

Collaborators and Investigators

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

Sponsor

Hawler Medical University

Investigators

  • Study Chair: Ariana Kh. Jawad, Assistant professor, KBMS
  • Study Chair: Bahar Q. Muhammad, CABOG, Maternity Teaching Hospital
  • Study Chair: Jinan N. Hassan, IBMS, Duhok university
  • Study Chair: Salim A. Salim, Master, Azhar University
  • Study Chair: Khalida M. Ameen, CABOG, karkuk Medical college
  • Study Chair: Maryam B. Mahmood, FICOG, Sulaimani Maternity Hospital
  • Study Chair: Khansa H. Abdul Rahman, MBChB, Maternity Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2016

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ACTUAL)

February 14, 2019

Study Registration Dates

First Submitted

February 19, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (ESTIMATE)

March 10, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HawlerMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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