Clinical Trial: Medical Management of Late Intrauterine Death.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Medical Management of Late Intrauterine Death Using a Therapeutic Combination of Isosorbide Dinitrate and Oxytocin.

Brief Summary: The purpose of this study is to assess the therapeutic efficacy and safety of isosorbide dinitrate-oxytocin in combination in the management of late intrauterine foetal death.

Detailed Summary:

A prospective, randomised, double-blind, controlled clinical trial (RCT) was conducted to compare the efficacy and clinical safety of the induction of labour using the combination of isosorbide dinitrate-oxytocin (experimental arm, X = 1) compared to misoprostol-oxytocin (standard arm, X = 0). The main result of the study was the success rate of foetal expulsion within 15 hours, while the average administration induction interval defined the secondary result. A total of 60 women with pregnancies greater than 20 weeks gestation were referred for foetal evacuation. We defined late intrauterine foetal death (IUFD) as babies without signs of life in the uterus after 20 complete weeks of pregnancy. The approval to conduct the study was obtained from the institutional board ethical committees of both hospitals. All participants were informed about the objectives of the study, and informed consent was required. Patients with the following characteristics were included: closed cervix without evidence of cervical dilation or baseline uterine activity, A Bishop score of <5, having intact membranes, gestation greater than or equal to 20 weeks established by the date of menstruation or by fetometry and ultrasound-confirmed late IUFD. This study did not include the medical management of multiple pregnancies, IUFD after late foeticide or the management of specific medical conditions associated with an increase in the risk of IUFD or patients with a history of hypertension, along with women with a history of unexplained antepartum haemorrhage, pelvic dystocia or any another counter-indications where medications were used. Patients were assigned through a computational random number generator to receive isosorbide dinitrate or misoprostol. Allocation to groups was predetermined and arranged in numerical order. All participants were given a vaginal exam by the same person, who was blinded to the treatment allocation. The medications w
Sponsor: National Institute of Perinatology

Current Primary Outcome: Rates of uterine expulsion in the women who received the isosorbide dinitrate-oxytocin regimen [ Time Frame: within 15 hours of administration ]

Original Primary Outcome: Same as current

Current Secondary Outcome: A Bishop score of >7 of administration of the first dose of isosorbide dinitrate [ Time Frame: within 12 hours ]

Original Secondary Outcome: Same as current

Information By: National Institute of Perinatology

Dates:
Date Received: June 26, 2015
Date Started: May 2008
Date Completion:
Last Updated: July 22, 2015
Last Verified: July 2015