Two Different Regimens of Misoprostol in Retained Placenta

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 1, 2019

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

Interventions

  • Drug: Misoprostol
    • 2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women

Arms, Groups and Cohorts

  • Active Comparator: 400 Microgram Misoprostol
    • Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group
  • Active Comparator: 800 Microgram Misoprostol
    • Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 15 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hawler Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Shahla Alalaf, Professor Shahla K.Alalaf – Hawler Medical University
  • Overall Official(s)
    • Shahla K. Alalaf, professor, Principal Investigator, Hawler Medical University
    • Namir G. Al Tawil, Professor, Study Director, Hawler Medical University
    • Ariana Kh. Jawad, Assistant professor, Study Chair, KBMS
    • Bahar Q. Muhammad, CABOG, Study Chair, Maternity Teaching Hospital
    • Jinan N. Hassan, IBMS, Study Chair, Duhok university
    • Salim A. Salim, Master, Study Chair, Azhar University
    • Khalida M. Ameen, CABOG, Study Chair, Karkuk Medical college
    • Maryam B. Mahmood, FICOG, Study Chair, Sulaimani Maternity Hospital
    • Khansa H. Abdul Rahman, MBChB, Study Chair, Maternity Teaching Hospital

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