Health TrialsbyHealthPanel

Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies

ConditionsPreterm BirthShort Cervix
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMỹ Đức Hospital

About this trial

This study compares the effectiveness of cervical cerclage with vaginal progesterone to vaginal progesterone only for the prevention of preterm birth in women with a singleton pregnancy and a short cervical length. Participants will be randomly assigned in a 1:1 ratio to receive cerclage plus progesterone or progesterone only.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Maternal age ≥18 years

Singleton pregnancy

Cervical length ≤ 25 mm, measured by TVS at the second-trimester ultrasonography (16 0/7 - 24 0/7 weeks of gestation)

Not participating in any other study which has intervention on maternity or fetus

Disqualifiers

Cervical dilation with visible amniotic membranes or amniotic membranes prolapsed into the vagina

Major congenital abnormalities of the fetus

Intrauterine fetal demise

Presence of severe vaginal discharge*

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cervical cerclage

    Procedure/Surgery

    Cervical cerclage using the McDonald technique under anaesthesia.

  • Vaginal progesterone

    Drug

    Cyclogest® 200mg, Actavis, United Kingdom, applied once daily at bedtime.

Treatment groups

328 Participants
are divided into 2 treatment groups
Group A: Combined therapy group (cervical cerclage plus vaginal progesterone)Experimental treatment 2 interventions
Group B: Progesterone only groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time from randomization to delivery

Number of days between randomization and delivery

Time frame
From date of randomization until the date of delivery

Secondary outcomes

1

Composite poor neonatal outcomes (major sencondary endpoint)

Stillbirth or neonatal death, intraventricular haemorrhage, respiratory distress syndrome, necrotizing enterocolitis or neonatal sepsis.

Time frame
From 20 weeks of gestation to 28 days after estimated due date
2

Miscarriage <22 weeks (late miscarriage)

spontaneous loss of pregnancy between 12 to 22 weeks is termed as late miscarriage

Time frame
From date of randomization to 22 weeks of gestation
3

Gestational age at delivery

Gestational age at delivery

Time frame
At delivery
4

Preterm birth <24 weeks, <28 weeks, <32 weeks, <34 weeks and <37 weeks of gestation

Preterm birth is defined as any birth ≥ 22 and \< 37 completed weeks of gestation. Any birth \< 22 weeks is defined as late miscarriage

Time frame
At delivery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mỹ Đức Hospital

Lead sponsor

Source ClinicalTrials.gov
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