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Completed

NCT Number: NCT02704780

Two Different Regimens of Misoprostol in Retained Placenta

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

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Key information

Conditions

Postpartum Haemorrhage Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Placenta Diseases Placenta, Retained Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Retained Placenta Urogenital Diseases Uterine Hemorrhage

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hawler Medical university

Erbil, Kurdistan Region, 44001, Iraq

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Misoprostol

Drug

2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women

Other names: Cytotic

Primary outcomes

  1. Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol

    Time frame: up to 30 minutes after intraumbilical injection

    complete delivery of placenta after injection of intraumbilical misoprostol

Secondary outcomes

  1. The amount of blood loss vaginally in both groups

    Time frame: up to 30 minutes after injection of placenta

    To estimate the amount of vaginal blood loss from time of injection of the the interventional drug and till the delivery of the placenta

  2. The time of delivery of placenta in both groups

    Time frame: up to 30 minutes after delivery of the placenta

    the time interval estimation from the injection to complete delivery of the placenta

  3. side effects of misoprostol

    Time frame: up to 24 hours after delivery of placenta

    Any side effects related to misoprostol after the injection (Fever, severing , diarrhea)

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

Umbilical Vein Injection of 800µg Misoprostol Versus 400 µg Misoprostol in the Treatment of Retained Placenta: A Multicenter, Randomized Double Blind Controlled Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2016
Registry last updated
Feb 22, 2019

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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