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
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.
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.
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