Pregnancy Clinical Trial
Official title:
Does Routine Membrane Sweeping in Uncomplicated Term Pregnancies Increase the Rate of Prelabour Rupture of Membranes
The purpose of this study is to determine if routine membrane sweeping in uncomplicated term pregnancies increases the rate of pre-labor rupture of membranes.
The question of routine membrane sweeping and prelabor rupture of membranes has not been
specifically addressed in a randomized control trial. A meta analysis of membrane sweeping
found ten publications which analyzed this question as a secondary outcome, though none of
these studies sought to analyze PROM in their objectives. This meta analysis found the
relative risk of prelabor rupture of membranes to be 1.14 with membrane sweeping, however
the confidence interval was 0.89 to 1.45 making the finding not significant. Despite this,
we feel that a study to specifically address this issue is warranted. The largest study in
the meta analysis (and the only one with a statistically significant difference on its own)
did find a significant risk of PROM. The studies in the meta analysis vary greatly in their
incidence of PROM, ranging from 2-39% in the membranes sweeping group and 2-26% in the
control groups. This wide variation, the fact these studies were not primarily designed to
compare PROM rates, and the reported 8-10% PROM in other texts and studies gives question to
the ability of this meta analysis to detect a difference in PROM rates between the two
groups. As the effect of membrane sweeping on PROM may influence clinicians attitudes toward
this intervention, further specific research is warranted.
Our Objective are:
1. To determine the rate of prelabor rupture of membranes in uncomplicated term
pregnancies undergoing routine membrane sweeping versus those without intervention. For
the purpose of this study, PROM is defined as the confirmation of ruptured amniotic
fluid with uterine contractions less than 10 minutes apart.
2. To determine the impact of membrane sweeping on successful labor induction for post
datism and pregnancies going past 41 weeks
3. To determine the impact of membrane sweeping and PROM with clinical variables
Patients will be randomized by a computer generated randomizer to either receive membrane
sweeping or vaginal exam without membrane sweeping. Patients will receive either membrane
sweeping or vaginal exam without membrane sweeping at each weekly visit from 38 weeks
gestation onwards. Patients in the no intervention group will receive no cervical evaluation
unless clinically indicated. Patients in the membrane sweeping group will have a finger
placed into the cervical os, the finger will be rotated in a 360 degree fashion which will
separate the amniotic membranes from by a circular motion. Patients in this group whose
cervix is not open enough to have the membranes swept will have it gently stretched and if
the cervix is closed it will be gently massaged to stimulate the release of prostaglandins
(1). Due to the nature of the intervention, it is not possible to blind the physician who is
performing the vaginal exam to which group the patient is in. However, the admitting and
delivering physicians will be blinded to the group allocations. This will minimize bias.
Such blinding will be done by having a patient identifier code in the chart which the clinic
physicians will use to access the randomizer online for determination of which exam to
perform. Admitting and delivering physicians will not access this code. Between 38 and 42
weeks gestation, clinical data from each prenatal visit will be kept to include patient age,
gestational age, parity, race, cervical exam, post-graduate year level of physician or if
the provider is a midwife or attending staff, and whether or not membrane sweeping was
performed. In Labor and Delivery data will then be collected on gestational age at delivery,
indication for admission, inductions, reason for induction, estimated gestational age at
delivery, PROM, cervical exam at admission, Bishop’s score on admission, labor outcomes,
route or delivery, pregnancy complications, neonatal complications, GBS status, and NICU
admissions. PROM as an indication for admission will be confirmed by nitrazine testing,
ferning test, and speculum examination. Two of the three tests must indicate PROM for the
patient to be given the diagnoses of PROM. PROM will be defined as the above positive
testing with contractions more than 10 minutes apart at the time of rupture of membranes. If
the PROM occurred just prior to the examination, this assessment will be made on the
tocometer. If the PROM occurred prior to the patient presenting to Labor and Delivery, this
assessment will be based on the patient’s subjective assessment of her contractions at the
time of membrane rupture. Labor is defined as regular contractions leading to cervical
change. The frequency of contractions required to cause cervical change varies from patient
to patient, however for the purpose of this study the patient will be considered to have
SROM (spontaneous rupture of membranes due to labor) if contractions are more frequent than
every 10 minutes. Patients will be analyzed on an intent to treat basis.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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