The Role of Uterine Artery Doppler Parameters in the Management of Retained Products of Conception.

NCT01775917 | Unknown DMC

• 1 other identifier: CMC-12-0106-CTIL
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

During the recent decades the need for surgical evacuation of the uterus in early miscarriages and incomplete miscarriages has been questioned. It has been shown that an observational approach can be, in many cases, as good as an invasive one without increasing the incidence of uterine infections. it has been shown that misoprostol - prostaglandin E1 given for missed abortions is successful in emptying the uterus in 85% of cases without any need for surgical intervention. and during recent years many women prefer this approach than the surgical one . Many have tried using sonographic signs such as endometrial thickness, the presence of a gestational sac, and color doppler to differ between blood clots and a gestational residua in uterus, and to decide according to these signs wether there is a need for surgical evacuation or an expectant management could be used. but none of these methods have been proven to be completely efficient as predictors. In this study the investigators will examine whether the doppler indices in the uterine arteries can help to predict which gestational residua needs surgical evacuation of the uterus and which could be managed expectantly. The study hypothesis is that the resistance in uterine artery doppler will be lower in cases with intrauterine residua as opposed to high resistance in cases without residua.

Conditions

Missed Abortion; Incomplete Abortion; Uterine Gestational Residua; Uterine Artery Doppler

Outcome Measures

Primary Outcomes (1)

• uterine artery doppler parameters

  comparison between uterine artery doppler parameters after complete abortion with misoprostol to doppler parameters in incomplete abortion with the need of surgical uterine evacuation. and in result to try and find a doppler value that could be used to predict the success of observational management in incomplete abortions or abortions with misoprostol.

  1 year

Secondary Outcomes (1)

• success rate of treatment of misoprostol in missed and incomplete abortions

  1 year

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

women of age 20-45 with missed abortion up to 8 weeks of pregnancy or incomplete abortion treated with misoprostol in the emergency room

You may not qualify if:

• known allergy to prostaglandins or NSAIDS
• heavy vaginal bleeding and hemodynamic instability
• multifetal gestation
• women with a clotting problems or treated with anticoagulant medications
• fever above 37.5 c
• anemia with hemoglobin \< 9/5 gr%
• missed abortion with CRL larger than 8 weeks of pregnancy
• diseases that can be aggravated by prostaglandins : severe asthma, uncontrolled blood pressure, glaucoma, sickle cell anemia, mitral stenosis

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Abortion, Missed; Abortion, Incomplete

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Grace Younes, M.D

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

grace younes, MD

CONTACT

972508845924; graceyounes@gmail.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 25, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 3, 2014

Record last verified: 2014-06

Locations

IL (1)