NCT01840813

Brief Summary

Administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta and the amount of blood loss vaginally.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
Last Updated

November 5, 2013

Status Verified

November 1, 2013

Enrollment Period

11 months

First QC Date

April 18, 2013

Last Update Submit

November 1, 2013

Conditions

Retained Placenta

Keywords

Intraumbilical misoprostolRetained placentaActive management of third stage of labour

Outcome Measures

Primary Outcomes (1)

  • delivery of placenta by medical intervention

    The administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta under general anaesthesia.

    30 minutes after the injection of misoprostol or normal saline in the umbilical vein

Secondary Outcomes (1)

  • vaginal bleeding after misoprostol use

    30 minutes after umbilical vein injection of misoprostol

Other Outcomes (1)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolabrity

    2 hours after umbilical vein injection of misoprostol

Study Arms (2)

Misoprostol

ACTIVE COMPARATOR

4 misoprostol tablets (Misotac® 200 micrograms tablet) dissolved in 20 ml of normal saline injected to umbilical vein

Drug: Misoprostol

Normal saline

PLACEBO COMPARATOR

Normal saline 0.9%, 20 ml was injected in the umbilical vein in cases of retained placenta

Drug: Normal saline

Interventions

MisoprostolDRUG

It is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance.

Also known as: (Misotac)® tablet
Misoprostol
Normal salineDRUG

It is a placebo group

Also known as: Normal saline 0.9%
Normal saline

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • women having singleton pregnancy
  • weeks of gestation or more delivered vaginally
  • prolongation of the third stage of labour (more than 30 min) following active management of third stage of labour

You may not qualify if:

  • Who refused to participate in the trial
  • Multiple pregnancies
  • Previous Caesarean Section
  • Haemodynamically unstable
  • Severe anaemia (haemoglobin less than 8gm/dl)
  • Chorioamnionitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maternity Teaching Hospital

Erbil, Kurdistan Region, 383-65, Iraq

Location

MeSH Terms

Conditions

Placenta, Retained

Interventions

MisoprostolSaline Solution

Condition Hierarchy (Ancestors)

Placenta DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Shahla K. Alalaf, Clinical M.D

    Hawler Medical University

    PRINCIPAL INVESTIGATOR

  • Sheelan S Rajab, High Diploma

    , Shaheed Dr.Khalid General Hospital, Directorate of Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 18, 2013

First Posted

April 26, 2013

Study Start

April 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

November 5, 2013

Record last verified: 2013-11

Locations

IR(1)