Intraumbilical Misoprostol in Retained Placenta

Overview

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.

Full Title of Study: “Intra-umbilical Injection of Misoprostol Versus Normal Saline in the Management of Retained Placenta: Intrapartum Placebo-controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2012

Detailed Description

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 .

Interventions

  • Drug: Misoprostol
    • It is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance.
  • Drug: Normal saline
    • It is a placebo group

Arms, Groups and Cohorts

  • Active Comparator: Misoprostol
    • 4 misoprostol tablets (MisotacĀ® 200 micrograms tablet) dissolved in 20 ml of normal saline injected to umbilical vein
  • Placebo Comparator: Normal saline
    • Normal saline 0.9%, 20 ml was injected in the umbilical vein in cases of retained placenta

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 15 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hawler Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Assistant Prof. Shahla Alalaf, Assistant Professor – Hawler Medical University
  • Overall Official(s)
    • Shahla K. Alalaf, Clinical M.D, Principal Investigator, Hawler Medical University
    • Sheelan S Rajab, High Diploma, Study Chair, , Shaheed Dr.Khalid General Hospital, Directorate of Health

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