Preterm Birth Clinical Trial
Official title:
The Effectiveness of Cervical Pessary Versus Vaginal Progesterone for the Prevention of Preterm Birth in Women With Singleton Pregnancies and Short Cervix: a Multicenter Randomized Controlled Trial
This study compares the effectiveness of cervical pessary to vaginal progesterone for
prevention of preterm birth in women with singleton pregnancies and a cervix ≤25 mm.
Participants will be randomly assigned in a 1:1 ratio to receive cervical pessary or vaginal
progesterone.
This open label, multi-center, randomized controlled trial aims to compare the effectiveness
of cervical pessary to vaginal progesterone for prevention of PTB in women with singleton
pregnancies and a cervix ≤25 mm.
All women at 16 0/7 to 22 0/7 weeks with singleton pregnancies will undergo cervical length
(CL) measurement and digital examination at screening routinely. Women with a CL ≤25 mm will
be eligible for the study.
Subjects meeting the study criteria will be randomized into two groups: (1) treated with
cervical pessary (Arabin) or (2) treated with 200 mg vaginal progesterone, once daily.
After written informed consent, women will be randomly assigned in a 1:1 ratio to receive a
cervical pessary or progesterone. Assignment to treatment allocation will be done via a web
portal hosted by HOPE Research Center, Vietnam. The randomization schedule will be
computer-generated at HOPE Research Center, with a permuted random block size of 2, 4 or 6.
Blinding will not be possible due to the nature of interventions.
For those who randomised to pessary group, a pessary certified by European Conformity
(Arabin®, Dr Arabin GmbH & Co KG, Germany) will be inserted through the vagina, upward around
the cervix by 2-4 senior clinicians, who had experienced with pessary used at each site,
within one week of randomization.
Women allocated to progesterone group will be receiving 200 mg vaginal progesterone,
purchased from the manufacturer (Cyclogest® 200 mg, Actavis, United Kingdom), once daily at
bedtime. They will be given a monitoring sheet and instructed to note everyday the date of
using.
In case of premature rupture of membranes, active vaginal bleeding, other signs of preterm
labor or severe patient discomfort, the pessary may be removed. If participants develop
(threatened) preterm labor, they will receive treatment per local protocol. Intervention will
be stopped at 370/7 weeks of gestation or at delivery.
Along side with this trial, another study will be conducted to determine how changes in
peripheral blood and cervical inflammatory markers are impacted by progesterone versus
pessary. Because of that, participants will be asked to take 5 ml blood sample and
cervical-vaginal discharge sampling at the time of randomization, 4-8 weeks after
randomization and before giving birth.
A cost-effectiveness analysis will also be conducted alongside this RCT. Data will be
reported in a separated paper.
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