An interventional study of Cervical pessary and Vaginal progesterone in Pregnancy, sponsored by Vietnam National University. Completed at 1 site in Vietnam. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-22.
Sponsored by Vietnam National University · Not applicable, Interventional, and Treatment
To compare the effectiveness of cervical pessary (Arabin) and vaginal progesterone for preventing premature birth in twin pregnancies after IVF
This will be a randomized controlled trial.
Women with twin pregnancies, at 16-22 weeks of gestation, will be invited to participate into the study.
Subjects meeting the study criteria will be randomized into two groups: (1) treated with cervical pessary (Arabin) or (2) treated with 400mg vaginal progesterone, once daily. Randomization will be done by third party via telephone, using a computer generated random list, with a variable block size of 2, 4 or 8. Apart from randomization, patients will be examined and treated according to local protocol.
Patients in pessary group will have an Arabin pessary placed within a week after randomization. A pessary certified by European Conformity (CE0482, MED/CERT ISO 9003/ EN 46003; Dr. Arabin, Witten, Germany) will be inserted through the vagina of the woman in the recumbent position and will be placed upward around the cervix. The research-team members who inserted the Arabin pessary have experience with Arabin pessary for singleton pregnancy before.
Patients in progesterone group will use vaginal progesterone (Cyclogest 400mg) once daily before bedtime, starting from the day of randomization onwards. They will be given a monitoring sheet and instructed to note everyday the date of using. If they forget one dose of any night, and remember it in the next morning or afternoon, they will use immediately the forgotten dose and continue with the dose of that day at night. If one dose is missed until the next evening, there will be no compensation use, they will only use the dose of the next day. Any change in using medication should be noted in the monitoring sheet.
In both groups, intervention will be stopped at 36 weeks of gestation or at delivery. All the participants will have follow-up visits every 4 weeks. If patients develop (threatened) preterm labor, they will receive treatment as routine practice.
Statistical analyses will be by intention to treat. For dichotomous endpoints, we will calculate rates. These will be compared by calculating a relative risk and a 95% confidence interval. Between-group differences in non-continuous variables will be assessed using the χ2-test. Results of continuous variables were given in mean ± SD or in percentage. Between-group differences of continuous variables were assessed with the Student's t-test. We will consider correlation between neonatal endpoints when we analyse at the level of the child. We assessed time to delivery by Cox proportional hazard analysis and Kaplan-Meier estimates, and compared results with a log-rank test. We plan an exploratory subgroup analysis in women with a cervical length of less than the 25th percentile (according to the distribution in all twins), as well as 25th - 50th percentile, 50th - 75th percentile and > 75th percentile. We also plan an exploratory subgroups analyses for chorionicity. A p-value \< 0.05 will be considered to indicate a statistically significant difference. The analysis will be done with statistical Package for Social Sciences version 19 (SPSS, USA).
Sample size has been set at 290. This was incorporated in an amendment of the protocol, and was approved by the IRB on 22 Sept 2016.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 300 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Vietnam National University is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible for enrolment into this trial, each female subject must fulfil all of the following criteria at the start of enrolment, unless specified otherwise:
Exclusion Criteria:
To be eligible for enrolment in this study each subject must not meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cervical pessary (Arabin) will be inserted to participants at 16-22 weeks and removed at 36 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort.
Device: Cervical pessary
Vaginal progesterone (Cyclogest 400 mg) once a day will be used, from 16-22 to 36 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort.
Drug: Vaginal progesterone
Arabin (cervical pessary) will be inserted at 16-22 weeks and removed at 36 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort
Also known as: Arabin
Vaginal progesterone (Cyclogest 400 mg) once a day will be used, from 16-22 to 36 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort
Also known as: Cyclogest 400mg
Preterm birth before 34 weeks of gestation
Birth before 34 weeks
Time frame: At birth
Intrauterine death before 24 weeks of gestation
Death of any fetus intrauterine before 24 weeks
Time frame: From randomisation to 24 weeks
Stillbirth
Baby born with no signs of life at or after 28 weeks
Time frame: At birth
Delivery before 24 weeks of gestation
Birth before 24 weeks
Time frame: At birth
Delivery before 28 weeks of gestation
Birth before 28 weeks
Time frame: At birth
Delivery before 32 weeks of gestation
Birth before 32 weeks
Time frame: At birth
Delivery before 37 weeks of gestation
Birth before 37 weeks
Time frame: At birth
Labour induction
Labor initiated with a method such as oxytocin, Foley bulb, or artificial rupture of membranes.
Time frame: At birth
Prelabour rupture of membrane
Prelabour rupture of membranes and gestational age less than 37 weeks
Time frame: From randomization to less than 37 weeks
Mode of delivery
Spontaneous, forceps/ventouse, emergency C-section, planned C-section
Time frame: At birth
Livebirth at any gestational age
Birth of at least one newborn that exhibits any sign of life, such as respiration, heartbeat, umbilical pulsation or movement of voluntary muscles
Time frame: At birth
Use of tocolytics drug
Use of tocolytics drug to prevent premature labor
Time frame: From 24 weeks to 34 weeks
Use of corticosteroids
Use of corticosteroids to prevent respiratory distressed syndrome
Time frame: From 24 weeks to 34 weeks
Admission days for preterm labor
Days admission to hospital due to preterm labor
Time frame: From 24 weeks to 37 week
Choriamnionitis
Intraamniotic infection
Time frame: From randomization to birth
Maternal morbidity
Thromboembolic complications, urinary tract infection treated with antibiotics, pneumonia, endometritis, hypertension disorder, eclampsia or HELLP syndrome, or death
Time frame: From randomization to birth
Birthweight
Weight of babies
Time frame: At birth
Birthweight < 1500g
Weight of babies \< 1500g
Time frame: At birth
Birthweight < 2500g
Weight of babies \< 2500g
Time frame: At birth
Congenital anomalies
Congenital malformation of newborn
Time frame: At birth
5-minute Apgar score
Apgar score at 5 minute after birth
Time frame: At birth
5-minute Apgar score < 7
Apgar score \< 7 at 5 minute after birth
Time frame: At birth
Admission to NICU
The admittance of newborn to NICU
Time frame: Within 7 days after delivery
Length of NICU admission
Number of days admittance of newborn to NICU
Time frame: Up to 28 days after birth
Severe respiratory distress syndrome
Grade 2 or worse, as diagnosed by Giedion et al
Time frame: Within 24 hours after delivery
Bronchopulmonary dysplasia
Diagnosed according to the international consensus guideline as described by Jobe and Bancalari
Time frame: At time of discharge home or at 36 weeks of gestational age
Intraventricular haemorrhage
Grade II B or worse, as diagnosed by repeated neonatal cranial ultrasound by the neonatologist according to the guidelines on neuro-imaging described by de Vries et al. and Ment et al
Time frame: Up to 28 days after birth
Necrotising enterocolitis
\> stage 1, will be diagnosed according to Bell
Time frame: Up to 28 days after birth
Proven sepsis
The combination of clinical signs and positive blood cultures.
Time frame: Up to 28 days after birth
Death before discharge
Death of newborn before discharge from nursery
Time frame: Up to 28 days after birth
Maternal side effects
Vaginal discharge, fever, other signs of infections, pain, pessary repositioning and necrosis or rupture of the cervix
Time frame: From randomisation to birth
Withdrawal from treatment
Patient's discontinuation of arabin or vaginal progesterone use
Time frame: From randomization to 36 weeks of gestation
Ran from Mar 2016 to primary completion in Nov 2017, 19 months.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 19 months is below that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Progesterone
Vietnam National University