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Intraumbilical Misoprostol in Retained Placenta

Primary Purpose

Retained Placenta

Status
Completed
Phase
Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Misoprostol
Normal saline
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retained Placenta focused on measuring Intraumbilical misoprostol, Retained placenta, Active management of third stage of labour

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women having singleton pregnancy
  • 28 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

Exclusion Criteria:

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

Sites / Locations

  • Maternity Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Misoprostol

Normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

vaginal bleeding after misoprostol use
using intraumbilical misoprostol in women with retained placenta reduces the amount of blood loss vaginally.

Full Information

First Posted
April 18, 2013
Last Updated
November 1, 2013
Sponsor
Hawler Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01840813
Brief Title
Intraumbilical Misoprostol in Retained Placenta
Official Title
Intra-umbilical Injection of Misoprostol Versus Normal Saline in the Management of Retained Placenta: Intrapartum Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University

4. Oversight

5. Study Description

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.
Detailed Description
Retained placenta (RP)is one of the complications of third stage of labour; it should be managed promptly as it may cause severe bleeding, infection, maternal morbidity and mortality .The current standard management of RP word wide, by manual removal aims to prevent these problems, but it is unsatisfactory method because it requires general anaesthesia in hospital, It is an invasive procedure with its own serious complications of bleeding, infection and genital tract injury. Umbilical vein injection of misoprostol is a simple, safe method and could be performed at the place of delivery .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retained Placenta
Keywords
Intraumbilical misoprostol, Retained placenta, Active management of third stage of labour

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol
Arm Type
Active Comparator
Arm Description
4 misoprostol tablets (Misotac® 200 micrograms tablet) dissolved in 20 ml of normal saline injected to umbilical vein
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Normal saline 0.9%, 20 ml was injected in the umbilical vein in cases of retained placenta
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
(Misotac)® tablet
Intervention Description
It is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Normal saline 0.9%
Intervention Description
It is a placebo group
Primary Outcome Measure Information:
Title
delivery of placenta by medical intervention
Description
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.
Time Frame
30 minutes after the injection of misoprostol or normal saline in the umbilical vein
Secondary Outcome Measure Information:
Title
vaginal bleeding after misoprostol use
Description
using intraumbilical misoprostol in women with retained placenta reduces the amount of blood loss vaginally.
Time Frame
30 minutes after umbilical vein injection of misoprostol
Other Pre-specified Outcome Measures:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolabrity
Description
Local applications of misoprostol through umbilical vein is associated with less side effects like shivering, fever, dizziness vomiting, flushes, nausea, abdominal pain and headache
Time Frame
2 hours after umbilical vein injection of misoprostol

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women having singleton pregnancy 28 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 Exclusion Criteria: Who refused to participate in the trial Multiple pregnancies Previous Caesarean Section Haemodynamically unstable Severe anaemia (haemoglobin less than 8gm/dl) Chorioamnionitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahla K. Alalaf, Clinical M.D
Organizational Affiliation
Hawler Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheelan S Rajab, High Diploma
Organizational Affiliation
, Shaheed Dr.Khalid General Hospital, Directorate of Health
Official's Role
Study Chair
Facility Information:
Facility Name
Maternity Teaching Hospital
City
Erbil city
State/Province
Kurdistan region
ZIP/Postal Code
383-65
Country
Iraq

12. IPD Sharing Statement

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Intraumbilical Misoprostol in Retained Placenta

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