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Trial record 24 of 25 for:    gestodene

Oral Contraceptive Pills Versus Expectant Management for Retained Pregnancy Products

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ClinicalTrials.gov Identifier: NCT03230825
Recruitment Status : Unknown
Verified August 2017 by Anat Hershko Klement, Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 26, 2017
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Anat Hershko Klement, Meir Medical Center

Brief Summary:
We speculate that the use of combined oral contraceptives may be a possible solution to promote the management of retained pregnancy products versus expectant management. By withdrawing the pill, the endometrium is expected to shed in a synchronized fashion (estrogen and progestin withdrawal bleeding and may also shed the retained products of conception and avoid a surgical procedure with its related potential complications.

Condition or disease Intervention/treatment Phase
Retained Products of Conception Post Abortion Drug: Oral contraceptive Other: Expectant management Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Once informed consent forms are signed, the patient will be randomized (using a randomization table handled by a 3rd party) into one of 2 groups:

  1. Expectant management of 3 weeks and a follow up visit a week after.
  2. Oral contraceptive agent, given for free, for 3 weeks and a follow up visit a week after treatment withdrawal.
Masking: Single (Outcomes Assessor)
Masking Description: Data analysis will be performed according to group code .
Primary Purpose: Treatment
Official Title: Oral Contraceptive Pills Versus Expectant Management for Retained Pregnancy Products After a First Trimester Miscarriage: a Randomized Clinical Trial
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Oral contraceptives
Oral contraceptive agent, given for free, for 3 weeks and a follow up visit a week after treatment withdrawal.
Drug: Oral contraceptive
Daily oral contraceptive agent for 3 weeks (FLAME, containing 0.02 mg Ethinylestradiol and 0.075 mg Gestodene)

Sham Comparator: Expectant management
Expectant management for 3 weeks and a follow up visit a week later.
Other: Expectant management
No intervention and a follow up visit a wewk later




Primary Outcome Measures :
  1. persistent retained pregnancy products rate [ Time Frame: 4 weeks ]
    rate



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Ages Eligible for Study:   16 Years to 54 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Retaiend pregnancy products
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients going through a Misoprostol or Misoprostol/Mifepristone induced procedure after a spontaneous 1st trimester pregnancy loss or as a 1st trimester planned pregnancy termination and present retained pregnancy products by a trans-vaginal ultrasound scan.
  2. Patients after a surgical evacuation of pregnancy products (dilatation and curettage - D&C) of a 1st trimester miscarriage and present retained pregnancy products by a trans-vaginal ultrasound scan.
  3. All retained products included are of a previously confirmed intra-uterine pregnancies.
  4. Asymptomatic patients or mild symptoms of bleeding (spotting).
  5. Presence of a measurable hyperechoic material by 2 dimensional TVUS

Exclusion Criteria:

  1. Retained products with any of the following clinical presentations : more than a mild vaginal bleeding, hemodynamic instability, signs of infection and/or abdominal pain.
  2. Any suspicion of a molar pregnancy.
  3. A known contra-indication for the use of oral contraceptives

Information from the National Library of Medicine

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): NCT03230825


Contacts
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Contact: Anat Hershko Klement, MD +972549170084 anat.klement@gmail.com

Sponsors and Collaborators
Meir Medical Center
Investigators
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Principal Investigator: Anat Hershko Klement, MD Meir Medical Center

Publications:
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Responsible Party: Anat Hershko Klement, Principal Investigator, Meir Medical Center
ClinicalTrials.gov Identifier: NCT03230825     History of Changes
Other Study ID Numbers: 0263-16
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Anat Hershko Klement, Meir Medical Center:
incomplete abortion
retained products of conception
combined oral contraceptives
ultrasound
Additional relevant MeSH terms:
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Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female