NCT02704780

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
509

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2016

Typical duration for phase_2

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

First Submitted

Initial submission to the registry

February 19, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

2.9 years

First QC Date

February 19, 2016

Last Update Submit

February 21, 2019

Conditions

Postpartum HaemorrhageRetained Placenta

Keywords

Retained placentaMisoprostoldouble blindRandomizationHaemorrhage

Outcome Measures

Primary Outcomes (1)

  • Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol

    complete delivery of placenta after injection of intraumbilical misoprostol

    up to 30 minutes after intraumbilical injection

Secondary Outcomes (3)

  • The amount of blood loss vaginally in both groups

    up to 30 minutes after injection of placenta

  • The time of delivery of placenta in both groups

    up to 30 minutes after delivery of the placenta

  • side effects of misoprostol

    up to 24 hours after delivery of placenta

Study Arms (2)

400 Microgram Misoprostol

ACTIVE COMPARATOR

Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group

Drug: Misoprostol

800 Microgram Misoprostol

ACTIVE COMPARATOR

Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group

Drug: Misoprostol

Interventions

MisoprostolDRUG

2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women

Also known as: Cytotic
400 Microgram Misoprostol800 Microgram Misoprostol

Eligibility Criteria

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

You may qualify if:

  • women with a singleton pregnancy, delivered vaginally
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hawler Medical university

Erbil, Kurdistan Region, 44001, Iraq

Location

Related Publications (1)

  • Kumar N, Jahanfar S, Haas DM, Weeks AD. Umbilical vein injection for management of retained placenta. Cochrane Database Syst Rev. 2021 Mar 11;3(3):CD001337. doi: 10.1002/14651858.CD001337.pub3.

    PMID: 33705565DERIVED

MeSH Terms

Conditions

Postpartum HemorrhagePlacenta, RetainedHemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPlacenta Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Shahla K. Alalaf, professor

    Hawler Medical University

    PRINCIPAL INVESTIGATOR

  • Namir G. Al Tawil, Professor

    Hawler Medical University

    STUDY DIRECTOR

  • 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

    Al-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

    STUDY CHAIR

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
Professor Shahla K.Alalaf

Study Record Dates

First Submitted

February 19, 2016

First Posted

March 10, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2019

Study Completion

February 14, 2019

Last Updated

February 22, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)