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

NCT00120042 | Completed Results

• 1 other identifier: EC04-68.1
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

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.

Conditions

Placenta, Retained; Postpartum Hemorrhage

Keywords

Abortion; Retained placenta; Hemorrhage; Postpartum ultrasound

Outcome Measures

Primary Outcomes (1)

• Placental Retention Rate

  If spontaneous expulsion of the placenta within 60 minutes of fetal delivery did not occur, digital exploration of the uterus in the operating room was planned.

  3 years

Secondary Outcomes (2)

• Post-Delivery Blood Loss

  3 years

• Endometrial Appearances Postpartum

  3 years

Study Arms (3)

1

NO INTERVENTION

No specific oxytocic to assist in placental delivery

2

ACTIVE COMPARATOR

Intramuscular oxytocin injection

Drug: Oxytocin

3

ACTIVE COMPARATOR

Oral misoprostol to assist in placental delivery

Drug: Misoprostol

Interventions

Misoprostol DRUG

600 mcg misoprostol swallowed after delivery of fetus

Also known as: Cytotec

3

Oxytocin DRUG

10 units oxytocin administered intramuscularly after delivery fetus

Also known as: Syntocinon

2

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Surgical termination
• Gestation less than 14 weeks or greater than 24 weeks

Sponsors & Collaborators

• The University of Western Australia: lead

Study Sites (1)

King Edward Memorial Hospital

Perth, Western Australia, 6008, Australia

Location

MeSH Terms

Conditions

Placenta, Retained; Postpartum Hemorrhage; Hemorrhage

Interventions

Misoprostol; Oxytocin

Condition Hierarchy (Ancestors)

Placenta Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Planned interim analysis not performed as mifepristone became available in Australia. Study ceased at 251 women and enough power available to calculate the groups as a single stage analysis.

Results Point of Contact

• Title: Dr Jan Dickinson
• Organization: The University of Western Australia

Jan.Dickinson@uwa.edu.au

61-8-93401330

Study Officials

• Jan E. Dickinson, MD

  The University of Western Australia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2005
• First Posted: July 14, 2005
• Study Start: February 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 9, 2009
• Results First Posted: June 1, 2009

Record last verified: 2009-06

Locations

AU (1)