Clinical Trial: Termination Of Anembryonic Pregnancy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Misoprostol Plus Isosorbide Mononitrate Versus Misoprostol For Termination Of Anembryonic Pregnancy

Brief Summary:

Anembryonic pregnancy is a leading cause of early miscarriage. The American Pregnancy Association estimates that blighted ovum causes approximately 50 percent of all first-trimester miscarriages. About 20 percent of all pregnancies result in miscarriage.

In general, there are 3 options for management of anembryonic pregnancy: expectant, medical, and surgical management. Expectant management consists of no intervention and awaiting natural passage of tissue. Medical management uses medication to expel uterine tissue. Surgical management is defined by mechanical removal of tissue from the uterus.

Medical management allows patients to avoid surgery and anesthesia. Patients may also feel that medical management is more private, and under their control. Several medications have been studied for medical management.

Misoprostol, a prostaglandin E1 analogue, is a uterotonic that results in cervical softening and contractions that expel the products of conception. It may be administered vaginally, orally, buccally, or sublingually. Adverse effects vary based on route of administration.

There is published literature on a wide range of therapeutic misoprostol regimens. Optimal dose and route of administration of misoprostol have not been determined by randomized trials. Overall, misoprostol is safe and well-tolerated.

Patients receiving misoprostol vaginally rather than orally have decreased adverse gastrointestinal effects and prolonged duration of action.

Oral misoprostol is less effective than vaginal misoprostol in emptying the uterus. Sublingual misoprostol is equivalent to vaginal misoprostol in inducing complete uterine emptying b

Detailed Summary:
Sponsor: Assiut University

Current Primary Outcome: The measurement of endometrial thickness by ultrasound in mm [ Time Frame: 6 months ]

Complete expulsion of remnant of conception is considered if endometrial thickness less than 10 mm and if more than 10 mm it considered incomplete expulsion.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Induction - abortion interval in hours [ Time Frame: 6 months ]
    The period from the start of administration of misoprostol until complete abortion
  • Induction dilatation interval in hours [ Time Frame: 6 month ]
    The period from the start of administration of misoprostol until the start of cervical dilatation measured during per vagina (P/V) examination
  • The occurrence of sever uncontrolled lower abdominal pain by visual analogue scale [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: Assiut University

Dates:
Date Received: October 8, 2015
Date Started: June 2015
Date Completion:
Last Updated: October 8, 2015
Last Verified: October 2015