Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption
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|ClinicalTrials.gov Identifier: NCT00120042|
Recruitment Status : Completed
First Posted : July 14, 2005
Results First Posted : June 1, 2009
Last Update Posted : July 9, 2009
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||251 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: 1
No specific oxytocic to assist in placental delivery
Active Comparator: 2
Intramuscular oxytocin injection
10 units oxytocin administered intramuscularly after delivery fetus
Other Name: Syntocinon
Active Comparator: 3
Oral misoprostol to assist in placental delivery
600 mcg misoprostol swallowed after delivery of fetus
Other Name: Cytotec
- Placental Retention Rate [ Time Frame: 3 years ]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.
- Post-Delivery Blood Loss [ Time Frame: 3 years ]Blood loss was assessed by weighing of pads and sheets in addition to clot
- Endometrial Appearances Postpartum [ Time Frame: 3 years ]
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): NCT00120042
|Australia, Western Australia|
|King Edward Memorial Hospital|
|Perth, Western Australia, Australia, 6008|
|Principal Investigator:||Jan E. Dickinson, MD||The University of Western Australia|