Misoprostol (Cytotec) is used widely in Obstetrics and Gynecology, whether for labor
induction (1), prevention (2), and treatment (3) of early postpartum hemorrhage (ePPH),
induced and missed abortions (4) and for cases suspected for having retained products of
conception postabortion and postpartum (RPOC, residua).
While it has been shown in previous studies that misoprostol is efficacious for most of the
above-mentioned indications, it is less well-established that the treatment for suspected
postpartum RPOC alters the natural course of events and reduces the number of patients
requiring surgical intervention and actually having RPOC.
RPOC is estimated to complicate about 1% of term pregnancies and is more prevalent than after
miscarriages and termination of pregnancy (5).
The diagnosis and treatment of RPOC might be challenging, as there are no clearly determined
diagnostic criteria, evidence-based guidelines or treatment protocols (6).
Different protocols for the follow-up and treatment of cases suspected of RPOC are in use
worldwide, including expectant management, administrating uterotonics, performing suction
curettage (6), and performing hysteroscopy (7, 8). Evidence in the literature supports the
treatment of RPOC with operative hysteroscopy since curettage seems to increase the risk for
intrauterine adhesions and Asherman syndrome (9, 10) with the possibility for menstrual
abnormalities, infertility or subfertility, recurrent pregnancy losses, preterm labor, and
preterm premature rupture of membranes (11).
Chambers et al published in 2009 a 6-year trial (12), which shows that treatment with 200 mcg
SL / PO misoprostol 3 times daily for 2 days may effectively treat RPOC and reduce repeat
curettage rate by 79.6%. There was also the complete resolution of symptoms in 93%, and 77%
of women reported a high level of satisfaction. The trial was retrospective and RPOC was not
confirmed by hysteroscopy or histology.
The main tool for diagnosis and follow-up in cases of RPOC is postpartum ultrasound, showing
low, medium, and high probability for residua, with the clinical symptoms of abnormal
bleeding pattern, abdominal tenderness, and persistently dilated cervix.
We've decided to set the categories according to the study by Smorgick (13), although we
chose to name them and treat them differently. The categories are:
Low probability for residua - ultrasound shows thin regular endometrial line 10 mm and
below, with no intrauterine mass or Doppler vascular flow.
In effect a normal ultrasound scan.
Medium probability for residua - ultrasound shows a cavity over 10 mm, intrauterine hypo
/ hyperechogenic mass, or irregular endometrial line without Doppler flow. With this
group, PROC cannot be excluded.
High probability for residua - with the addition of Doppler vascular flow to the cavity.
The natural course of the ultrasonic appearance of the uterine cavity postpartum (14) was
shown to take roughly 56 days for the cavity to appear empty in 95% percent of cases not
suspected of having RPOC.
This study aims to test prospectively expectant management compared to misoprostol
administration for a certain duration of time of cases with risk factors for RPOC, including
cases undergoing revision of the uterine cavity or manual lysis of placenta postpartum, early
postpartum hemorrhage, cases with a history of treated postpartum residua, having placental
pathology (succenturiate, bilobed placenta), a pregnancy that started as multifetal with only
one fetus reached advanced pregnancy, and patients undergoing Bumm curettage post-delivery.
- Aims Since the literature data on this subject is scarce and the treatment is challenging,
the primary aim of this study is to assess prospectively and randomly expectant management
vs. misoprostol administration (PV, PO, SL) on the treatment for suspected RPOC postpartum in
women with risk factors for residua along an 8-week duration as characterized by ultrasound
follow-up every 2-3 weeks and divided to a 3 tier system of the low, medium and high
probability of residua and the cases requiring hysteroscopy for suspected residua.
Secondary aims include side effects of treatment, late postpartum hemorrhage, blood
transfusion, and endomyometritis / PID and complications.
- Hypothesis In this study, we hypothesize that the treatment with misoprostol, compared to
expectant management, will be able to reduce the number of cases at medium and high
probability of residua as described by ultrasound and by that reduce the number of cases
requiring hysteroscopy and treatment of residua.