Oral Contraceptive Pills Versus Expectant Management for Retained Pregnancy Products

Retained Products of Conception Post Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03230825
• Other study ID #: 0263-16
• Status: Not yet recruiting
• Phase: N/A
• First received: July 24, 2017
• Last updated: August 6, 2017
• Start date: September 2017
• Est. completion date: December 2018

Study information

• Verified date: August 2017
• Source: Meir Medical Center
• Contact: Anat Hershko Klement, MD
• Phone: +972549170084
• Email: anat.klement[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 54 Years

Eligibility

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

Related Conditions & MeSH terms

• Retained Products of Conception Post Abortion

Intervention

Drug:
• Oral contraceptive
Daily oral contraceptive agent for 3 weeks (FLAME, containing 0.02 mg Ethinylestradiol and 0.075 mg Gestodene)

Other:
• Expectant management
No intervention and a follow up visit a wewk later

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

References & Publications (5)

Casikar I, Lu C, Oates J, Bignardi T, Alhamdan D, Condous G. The use of power Doppler colour scoring to predict successful expectant management in women with an incomplete miscarriage. Hum Reprod. 2012 Mar;27(3):669-75. doi: 10.1093/humrep/der433. Epub 2012 Jan 9. — View Citation

Chen BA, Creinin MD. Medical management of early pregnancy failure: efficacy. Semin Reprod Med. 2008 Sep;26(5):411-22. doi: 10.1055/s-0028-1087107. Epub 2008 Sep 29. Review. — View Citation

Griebel CP, Halvorsen J, Golemon TB, Day AA. Management of spontaneous abortion. Am Fam Physician. 2005 Oct 1;72(7):1243-50. Review. — View Citation

Sellmyer MA, Desser TS, Maturen KE, Jeffrey RB Jr, Kamaya A. Physiologic, histologic, and imaging features of retained products of conception. Radiographics. 2013 May;33(3):781-96. doi: 10.1148/rg.333125177. — View Citation

Wang X, Chen C, Wang L, Chen D, Guang W, French J. Conception, early pregnancy loss, and time to clinical pregnancy: a population-based prospective study. Fertil Steril. 2003 Mar;79(3):577-84. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	persistent retained pregnancy products rate	rate	4 weeks