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Completed

NCT Number: NCT01840813

Intraumbilical Misoprostol in Retained Placenta

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.

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Key information

Conditions

Retained Placenta Female Urogenital Diseases and Pregnancy Complications Placenta Diseases Placenta, Retained Pregnancy Complications Urogenital Diseases

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Maternity Teaching Hospital

Erbil, Kurdistan Region, 383-65, Iraq

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

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

Other names: (Misotac)® tablet

normal saline

Drug

It is a placebo group

Other names: Normal saline 0.9%

Primary outcomes

  1. delivery of placenta by medical intervention

    Time frame: 30 minutes after the injection of misoprostol or normal saline in the umbilical vein

    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 outcomes

  1. vaginal bleeding after misoprostol use

    Time frame: 30 minutes after umbilical vein injection of misoprostol

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

Other outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolabrity

    Time frame: 2 hours after umbilical vein injection of misoprostol

    Local applications of misoprostol through umbilical vein is associated with less side effects like shivering, fever, dizziness vomiting, flushes, nausea, abdominal pain and headache

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

Intra-umbilical Injection of Misoprostol Versus Normal Saline in the Management of Retained Placenta: Intrapartum Placebo-controlled Trial

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 26, 2013
Registry last updated
Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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