Clinical Trial: Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Optimisation of the Management of Placental Delivery in Second Trimester Pregnancy Interruption
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 vagina
Detailed Summary:
Methods:
All women who are admitted to King Edward Memorial Hospital for Women for pregnancy interruption for severe fetal anomaly or maternal pregnancy complications between 14 and 24 weeks gestation will be invited to participate in the study. No women with an intrauterine fetal demise will be recruited due to the potential confounding effects of the fetal death on the placental separation process.
Once consent has been obtained, the women will be randomised to three placental management strategy groups:
Group 1: Standard management protocol; Group 2: Oxytocin protocol; Group 3: Oral misoprostol protocol.
Group 1:
Women allocated to the standard management protocol will receive no routine oxytocic following the delivery of the fetus.
If spontaneous placental expulsion has not occurred within 60 minutes of delivery, or if heavy vaginal bleeding ensues within that time period, manual removal of the placenta will be performed in the operating room under general or regional anaesthesia. No cord traction is used to facilitate placental expulsion, although maternal expulsive efforts or digital extraction if the placenta is visible at the vaginal introitus are permissible.
Group 2:
Women allocated to the oxytocin protocol will receive a single intramuscular injection (IMI) into the upper thigh of 10 IU oxytocin (Syntocinon®) as soon as the fetus is expelled.
If placental expulsion has not occurred within 60 minutes of delivery, or if heavy vaginal bleeding ensues within that time
Sponsor: The University of Western Australia
Current Primary Outcome: Placental Retention Rate [ Time Frame: 3 years ]
Original Primary Outcome: Placental Retention Rate
Current Secondary Outcome:
- Post-Delivery Blood Loss [ Time Frame: 3 years ]
- Endometrial Appearances Postpartum [ Time Frame: 3 years ]
Original Secondary Outcome:
- Post-Delivery Blood Loss
- Endometrial Appearances Postpartum
Information By: The University of Western Australia
Dates:
Date Received: July 5, 2005
Date Started: February 2005
Date Completion:
Last Updated: June 29, 2009
Last Verified: June 2009
