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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Placenta, Retained; Postpartum Hemorrhage	Drug: Misoprostol; Drug: Oxytocin	Not Applicable

  Show Detailed Description

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	251 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption
Study Start Date :	February 2005
Actual Primary Completion Date :	December 2007
Actual Study Completion Date :	December 2007

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Placental Retention Rate [ Time Frame: 3 years ]

Secondary Outcome Measures :

1. Post-Delivery Blood Loss [ Time Frame: 3 years ]
2. Endometrial Appearances Postpartum [ Time Frame: 3 years ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	16 Years to 50 Years (Child, Adult)
Sexes 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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr Jan Dickinson, Associate Professor
ClinicalTrials.gov Identifier:	NCT00120042 History of Changes
Other Study ID Numbers:	EC04-68.1
First Posted:	July 14, 2005
Results First Posted:	June 1, 2009
Last Update Posted:	July 9, 2009
Last Verified:	June 2009

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; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Anti-Ulcer Agents; Gastrointestinal Agents