Two Different Regimens of Misoprostol in Retained Placenta
Primary Purpose
Postpartum Haemorrhage, Retained Placenta
Status
Completed
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
Misoprostol
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Haemorrhage focused on measuring Retained placenta, Misoprostol, double blind, Randomization, Haemorrhage
Eligibility Criteria
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
Sites / Locations
- Hawler Medical university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
400 Microgram Misoprostol
800 Microgram Misoprostol
Arm Description
Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group
Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The amount of blood loss vaginally in both groups
To estimate the amount of vaginal blood loss from time of injection of the the interventional drug and till the delivery of the placenta
The time of delivery of placenta in both groups
the time interval estimation from the injection to complete delivery of the placenta
side effects of misoprostol
Any side effects related to misoprostol after the injection (Fever, severing , diarrhea)
Full Information
NCT ID
NCT02704780
First Posted
February 19, 2016
Last Updated
February 21, 2019
Sponsor
Hawler Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02704780
Brief Title
Two Different Regimens of Misoprostol in Retained Placenta
Official Title
Umbilical Vein Injection of 800µg Misoprostol Versus 400 µg Misoprostol in the Treatment of Retained Placenta: A Multicenter, Randomized Double Blind Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Haemorrhage, Retained Placenta
Keywords
Retained placenta, Misoprostol, double blind, Randomization, Haemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
509 (Actual)
8. Arms, Groups, and Interventions
Arm Title
400 Microgram Misoprostol
Arm Type
Active Comparator
Arm Description
Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group
Arm Title
800 Microgram Misoprostol
Arm Type
Active Comparator
Arm Description
Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Cytotic
Intervention Description
2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women
Primary Outcome Measure Information:
Title
Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol
Description
complete delivery of placenta after injection of intraumbilical misoprostol
Time Frame
up to 30 minutes after intraumbilical injection
Secondary Outcome Measure Information:
Title
The amount of blood loss vaginally in both groups
Description
To estimate the amount of vaginal blood loss from time of injection of the the interventional drug and till the delivery of the placenta
Time Frame
up to 30 minutes after injection of placenta
Title
The time of delivery of placenta in both groups
Description
the time interval estimation from the injection to complete delivery of the placenta
Time Frame
up to 30 minutes after delivery of the placenta
Title
side effects of misoprostol
Description
Any side effects related to misoprostol after the injection (Fever, severing , diarrhea)
Time Frame
up to 24 hours after delivery of placenta
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahla K. Alalaf, professor
Organizational Affiliation
Hawler Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Namir G. Al Tawil, Professor
Organizational Affiliation
Hawler Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ariana Kh. Jawad, Assistant professor
Organizational Affiliation
KBMS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bahar Q. Muhammad, CABOG
Organizational Affiliation
Maternity Teaching Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jinan N. Hassan, IBMS
Organizational Affiliation
Duhok university
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Salim A. Salim, Master
Organizational Affiliation
Azhar University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Khalida M. Ameen, CABOG
Organizational Affiliation
Karkuk Medical college
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maryam B. Mahmood, FICOG
Organizational Affiliation
Sulaimani Maternity Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Khansa H. Abdul Rahman, MBChB
Organizational Affiliation
Maternity Teaching Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hawler Medical university
City
Erbil
State/Province
Kurdistan Region
ZIP/Postal Code
44001
Country
Iraq
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33705565
Citation
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.
Results Reference
derived
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Two Different Regimens of Misoprostol in Retained Placenta
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