Oral Contraceptive Pills Versus Expectant Management for Retained Pregnancy Products

August 6, 2017 updated by: Anat Hershko Klement, Meir Medical Center

Oral Contraceptive Pills Versus Expectant Management for Retained Pregnancy Products After a First Trimester Miscarriage: a Randomized Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Miscarriage is a common event in general gynaecological practice, and is an age-dependent outcome. It is estimated -that approximately 20 percent of clinically recognized pregnancies will result in a miscarriage, and the prevalence is much higher if preclinical pregnancies are included as well .Failure to pass the contents of the pregnancy is reported in 15% of patients going through a spontaneous 1st trimester miscarriage and a similar rate in patients going through an induced medical abortion after a spontaneous pregnancy loss (miscarriage) and planned pregnancy termination using PGE1 (MisWe speculate that the use of combined oral contraceptives may be a possible solution to promote the management of retained pregnancy products versus expectant management. The exposure to combined oral contraceptives is known to induce secretory and decidual changes in the endometrium .By withdrawing the pill, the endometrium is expected to shed in a synchronized fashion (estrogen and progestin withdrawal bleeding). We hypothesize that such withdrawal bleeding may also shed the retained products of conception and avoid a surgical procedure with its related potential complications. oprostol).

All patients diagnosed with RPOC according to the inclusion and exclusion criteria , will be asked to give their informed consent to take part in the study.

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.

We wish to emphasize that the current management in our ward is expectant management in the population eligible for this study.

All US scans will be performed by 2 qualified sonographers using a 7.5 MHz transvaginal transducer. 2D images in both sagittal and axial planes will be obtained. Sonographic features to be evaluated are: endometrial maximal thickness measured in the sagittal plan, presence or absence and size of an endometrial mass (3 dimensions) and grading of endometrial vascularity. Vascularity will be graded as type 0, 1, 2 or 3 defining no detectable, minimal (less then myometrium), moderate (nearly equal to myometrium) or marked vascularity respectively (4).

At enrollment the patient will be monitored and interviewed for the following variables :

Age, BMI, OB - GYN history, smoking status, Blood pressure, pulse rate,Temperature, blood count, HCG levels.

All patients will be invited to a follow up visit 3 weeks after randomization. The follow up visit will include again an ultrasound scan as described above.

In any case the patient is reporting a menstrual bleeding/ abdominal pain/ fever she will contact the 24hr available ER of the ward and will be evaluated for complications. After evaluation is completed the principal investigator will be contacted and the case will be discussed as for the need for additional measures and documented in the research file.

In the planned 4 week post randomization visit the following parameters will be monitored:

Blood pressure, pulse rate, Temperature, blood count, HCG levels as well as a review of any symptoms.

Following the interview a trans-vaginal scan will be performed in order to evaluate the cavity and any retained products existence and any presence of blood flow in case of a positive diagnosis.

In any case of retained products detected by ultrasound we will recommend a surgical hysteroscopy.

The oral contraceptives will be donated by DEXCEL LTD, ISRAEL to the hospital pharmacy, where it will be stored.

Brand name :FLAME containing 0.02 mg Ethinylestradiol and 0.075 mg Gestodene. Israeli authorities demand that a drug which is tested in a research will be provided to the participant without charging.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 54 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
persistent retained pregnancy products rate
Time Frame: 4 weeks
rate
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Anat Hershko Klement, MD, Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2017

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (Actual)

July 26, 2017

Study Record Updates

Last Update Posted (Actual)

August 8, 2017

Last Update Submitted That Met QC Criteria

August 6, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0263-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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