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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

About this trial

This is an interventional treatment trial for Postpartum Haemorrhage focused on measuring Retained placenta, Misoprostol, double blind, Randomization, Haemorrhage

Eligibility Criteria

15 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

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

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: