Intraumbilical Misoprostol in Retained Placenta

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

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.

Study Overview

• Status: Completed
• Conditions: Retained Placenta
• Intervention / Treatment: Drug: Misoprostol; Drug: Normal saline

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 .

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• Iraq
  • Kurdistan region
    • Erbil city, Kurdistan region, Iraq, 383-65
      • Maternity Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Misoprostol; 4 misoprostol tablets (Misotac® 200 micrograms tablet) dissolved in 20 ml of normal saline injected to umbilical vein	Drug: Misoprostol; It is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance.; Other Names: (Misotac)® tablet
Placebo Comparator: Normal saline; Normal saline 0.9%, 20 ml was injected in the umbilical vein in cases of retained placenta	Drug: Normal saline; It is a placebo group; Other Names: Normal saline 0.9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
delivery of placenta by medical intervention	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.	30 minutes after the injection of misoprostol or normal saline in the umbilical vein

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vaginal bleeding after misoprostol use	using intraumbilical misoprostol in women with retained placenta reduces the amount of blood loss vaginally.	30 minutes after umbilical vein injection of misoprostol

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolabrity	Local applications of misoprostol through umbilical vein is associated with less side effects like shivering, fever, dizziness vomiting, flushes, nausea, abdominal pain and headache	2 hours after umbilical vein injection of misoprostol

Collaborators and Investigators

• Sponsor: Hawler Medical University
• Investigators: Principal Investigator: Shahla K. Alalaf, Clinical M.D, Hawler Medical University; Study Chair: Sheelan S Rajab, High Diploma, , Shaheed Dr.Khalid General Hospital, Directorate of Health

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: April 18, 2013
• First Submitted That Met QC Criteria: April 25, 2013
• First Posted (Estimate): April 26, 2013

Study Record Updates

• Last Update Posted (Estimate): November 5, 2013
• Last Update Submitted That Met QC Criteria: November 1, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Intraumbilical misoprostol; Retained placenta; Active management of third stage of labour
• Additional Relevant MeSH Terms: Pregnancy Complications; Placenta Diseases; Placenta, Retained; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: HMU911