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Intraumbilical Misoprostol in Retained Placenta

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ClinicalTrials.gov Identifier: NCT01840813
Recruitment Status : Completed
First Posted : April 26, 2013
Last Update Posted : November 5, 2013
Sponsor:
Information provided by (Responsible Party):
Assistant Prof. Shahla Alalaf, Hawler Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Retained Placenta Drug: Misoprostol Drug: Normal saline Phase 1

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-umbilical Injection of Misoprostol Versus Normal Saline in the Management of Retained Placenta: Intrapartum Placebo-controlled Trial
Study Start Date : April 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

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 Name: (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 Name: Normal saline 0.9%




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840813


Locations
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Iraq
Maternity Teaching Hospital
Erbil city, Kurdistan region, Iraq, 383-65
Sponsors and Collaborators
Hawler Medical University
Investigators
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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

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Responsible Party: Assistant Prof. Shahla Alalaf, Assistant Professor, Hawler Medical University
ClinicalTrials.gov Identifier: NCT01840813     History of Changes
Other Study ID Numbers: HMU911
First Posted: April 26, 2013    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013
Keywords provided by Assistant Prof. Shahla Alalaf, Hawler Medical University:
Intraumbilical misoprostol
Retained placenta
Active management of third stage of labour
Additional relevant MeSH terms:
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Placenta, Retained
Placenta Diseases
Pregnancy Complications
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics