Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption

This study has been completed.
Sponsor:
Information provided by:
The University of Western Australia
ClinicalTrials.gov Identifier:
NCT00120042
First received: July 5, 2005
Last updated: June 29, 2009
Last verified: June 2009
  Purpose

Interruption of a pregnancy after 14 weeks gestation may be required when the fetus is dead, severely malformed or in cases of maternal illness. This process is usually conducted medically in Australia, using the prostaglandin E1 analogue misoprostol. This prostaglandin, although not specifically licensed for use in pregnancy termination, is now a common abortifacient with a lot of accumulated experience both within Australia and internationally.

Since 1996, misoprostol, a synthetic prostaglandin, has been used at King Edward Memorial Hospital as the principal agent for second trimester pregnancy termination. This agent is administered vaginally, and in its current form and dosage regimen results in 75-80% of women delivering within 24 hours. As experience with this agent has grown, it has been observed that in approximately 40% of women the placenta is either completely retained or incompletely delivered, necessitating operative removal and an increased potential for maternal blood loss. In this study, it is planned, in a randomized controlled clinical trial, to evaluate three regimens for the management of placental delivery in women undergoing second trimester pregnancy interruption. The primary intention of this study is to develop a third stage management protocol to reduce the incidence of placental retention in second trimester medical pregnancy termination.

The secondary aim of this study is to assess the ultrasound appearance of the uterus and its cavity within 24 hours of second trimester pregnancy termination. The ultrasound appearances of the uterus following second trimester pregnancy loss have not been previously investigated in detail. Previous ultrasound studies of the term postpartum uterus have demonstrated a high incidence of echogenic material within the uterine cavity soon after an uncomplicated vaginal delivery. These findings have been of concern as the ultrasound appearances may erroneously imply a need for operative intervention. The investigators wish to ascertain if this high incidence of echogenic tissue presence is also true in the second trimester. Ultrasound is frequently used by clinicians to define placental completeness and the potential requirement for surgical curettage. The data from this single sonographic examination of the uterus will provide baseline data for a planned longitudinal study of uterine appearances following second trimester pregnancy loss and their correlation with clinical symptoms.


Condition Intervention
Placenta, Retained
Postpartum Hemorrhage
Drug: Misoprostol
Drug: Oxytocin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption

Resource links provided by NLM:


Further study details as provided by The University of Western Australia:

Primary Outcome Measures:
  • Placental Retention Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-Delivery Blood Loss [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Endometrial Appearances Postpartum [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 251
Study Start Date: February 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
No specific oxytocic to assist in placental delivery
Active Comparator: 2
Intramuscular oxytocin injection
Drug: Oxytocin
10 units oxytocin administered intramuscularly after delivery fetus
Other Name: Syntocinon
Active Comparator: 3
Oral misoprostol to assist in placental delivery
Drug: Misoprostol
600 mcg misoprostol swallowed after delivery of fetus
Other Name: Cytotec

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Abortion at 14-24 weeks gestation
  • Live fetus
  • Medical termination with vaginal misoprostol

Exclusion Criteria:

  • Surgical termination
  • Gestation less than 14 weeks or greater than 24 weeks
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120042

Locations
Australia, Western Australia
King Edward Memorial Hospital
Perth, Western Australia, Australia, 6008
Sponsors and Collaborators
The University of Western Australia
Investigators
Principal Investigator: Jan E. Dickinson, MD The University of Western Australia
  More Information

No publications provided

Responsible Party: Dr Jan Dickinson, Associate Professor
ClinicalTrials.gov Identifier: NCT00120042     History of Changes
Other Study ID Numbers: EC04-68.1
Study First Received: July 5, 2005
Results First Received: April 1, 2009
Last Updated: June 29, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by The University of Western Australia:
Abortion
Retained placenta
Hemorrhage
Postpartum ultrasound

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Placenta, Retained
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Placenta Diseases
Oxytocin
Misoprostol
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 30, 2014