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Intraumbilical Misoprostol in Retained Placenta

NCT ID: NCT01840813

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-03-31

Brief Summary

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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

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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 .

Conditions

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Retained Placenta

Keywords

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Intraumbilical misoprostol Retained placenta Active management of third stage of labour

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Misoprostol

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

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

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

Normal saline

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

It is a placebo group

Interventions

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Misoprostol

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

Intervention Type DRUG

Normal saline

It is a placebo group

Intervention Type DRUG

Other Intervention Names

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(Misotac)® tablet Normal saline 0.9%

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hawler Medical University

OTHER

Sponsor Role lead

Responsible Party

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Assistant Prof. Shahla Alalaf

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shahla K. Alalaf, Clinical M.D

Role: PRINCIPAL_INVESTIGATOR

Hawler Medical University

Sheelan S Rajab, High Diploma

Role: STUDY_CHAIR

, Shaheed Dr.Khalid General Hospital, Directorate of Health

Locations

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Maternity Teaching Hospital

Erbil, Kurdistan Region, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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HMU911

Identifier Type: -

Identifier Source: org_study_id