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Pessary Versus Cerclage With or Without Progesterone in Twins (PCEP_Twins)

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ClinicalTrials.gov Identifier: NCT03863613
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
My Duc Phu Nhuan Hospital
Information provided by (Responsible Party):
Mỹ Đức Hospital

Brief Summary:

This study compares the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone for prevention of preterm birth in women with a twin pregnancy and a cervix ≤28 mm.

Participants will be randomly assigned in a 1:1:1:1 ratio to receive cerclage, pessary, cerclage plus progesterone or pessary plus progesterone.


Condition or disease Intervention/treatment Phase
Preterm Birth Twin Pregnancy Short Cervix Device: Pessary Procedure: Cervical cerclage Drug: Vaginal progesterone Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Participants will be randomised to either cerclage, pessary, cerclage plus progesterone or pessary plus progesterone in a 1:1:1:1 ratio with a variable block size of 4 or 8.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effectiveness of Cervical Pessary Compared to Cervical Cerclage With or Without Vaginal Progesterone for the Prevention of Preterm Birth in Women With a Twin Pregnancy and a Very Short Cervix: a Randomised Controlled Trial
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Pessary group
A soft, flexible, silicone pessary, purchased from the manufacturer (Arabin®, Dr Arabin GmbH & Co KG, Germany) will be inserted through the vagina, upward around the cervix by 4 senior clinicians, who had experienced with pessary used, within one week of randomisation. Size of the pessary will be determined at the time of speculum inspection.
Device: Pessary
A soft, flexible, silicone pessary (Arabin®, Dr Arabin GmbH & Co KG, Germany) will be inserted through the vagina, upward around the cervix.
Other Name: Arabin

Active Comparator: Cerclage group
Women will be receiving the cervical cerclage according to local protocol, within a week after randomisation. 3 senior clinicians who had experienced with cerclage, will perform cerclage, using Mc Donald technique, under spinal anaesthesia.
Procedure: Cervical cerclage
Cervical cerclage using Mc Donald technique, under anaesthesia
Other Name: Stitch

Active Comparator: Pessary plus progesterone group
400 mg vaginal progesterone, purchased from the manufacturer (Cyclogest® 400mg, Actavis, United Kingdom), will be applied once daily at bedtime, starting from the day of randomisation, in addition to the pessary that has been placed. Participants will be asked to record their drug application in a patient diary sheet for up to 140 days.
Device: Pessary
A soft, flexible, silicone pessary (Arabin®, Dr Arabin GmbH & Co KG, Germany) will be inserted through the vagina, upward around the cervix.
Other Name: Arabin

Drug: Vaginal progesterone
Cyclogest® 400mg, Actavis, United Kingdom, applied once daily at bedtime
Other Name: Cyclogest 200 mg

Active Comparator: Cerclage plus progesterone group
400 mg vaginal progesterone, purchased from the manufacturer (Cyclogest® 400mg, Actavis, United Kingdom), will be applied once daily at bedtime, starting from the day of randomisation, in addition to the cerclage that has been placed. Participants will be asked to record their drug application in a patient diary sheet for up to 140 days.
Procedure: Cervical cerclage
Cervical cerclage using Mc Donald technique, under anaesthesia
Other Name: Stitch

Drug: Vaginal progesterone
Cyclogest® 400mg, Actavis, United Kingdom, applied once daily at bedtime
Other Name: Cyclogest 200 mg




Primary Outcome Measures :
  1. Preterm birth <34 weeks [ Time Frame: From date of randomisation until 33 6/7 weeks ]
    Birth before 34 weeks' gestation


Secondary Outcome Measures :
  1. Gestational age at delivery [ Time Frame: At birth ]
    Gestational age at delivery Time from randomisation to delivery Delivery < 24 weeks, < 28 weeks, < 32 weeks and < 37 weeks of gestation Spontaneous preterm birth < 24 weeks, < 28 weeks, < 32 weeks and < 37 weeks of gestation Onset of labor: spontaneous, labor induction, elective C-section Mode of delivery: vaginal delivery, C-section All livebirths at any gestational age Use of tocolytic drugs Use of antenatal corticosteroids Use of magnesium sulfat for fetal neuroprotection Preterm prelabour rupture of membranes Length of maternal admission for preterm labor (days) Chorioamnionitis Marternal mortality

  2. Time from randomisation to delivery [ Time Frame: From date of randomisation until the date of delivery, assessed up to 22 weeks ]
    Time interval between randomisation and delivery

  3. Preterm birth <28 weeks [ Time Frame: From date of randomisation until 27 6/7 weeks ]
    Birth before 28 weeks' gestation

  4. Preterm birth <37 weeks [ Time Frame: From date of randomisation until 36 6/7 weeks ]
    Birth before 37 weeks' gestation

  5. Spontaneous preterm birth <28 weeks [ Time Frame: From date of randomisation until 27 6/7 weeks ]
    Birth spontaneously before 28 weeks' gestation, including preterm spontaneous rupture of membranes, preterm premature rupture of membranes (PPROM)

  6. Spontaneous preterm birth <34 weeks [ Time Frame: From date of randomisation until 33 6/7 weeks ]
    Birth spontaneously before 34 weeks' gestation, including preterm spontaneous rupture of membranes, preterm premature rupture of membranes (PPROM)

  7. Spontaneous preterm birth <37 weeks [ Time Frame: From date of randomisation until 36 6/7 weeks ]
    Birth spontaneously before 37 weeks' gestation, including preterm spontaneous rupture of membranes, preterm premature rupture of membranes (PPROM)

  8. Iatrogenic preterm birth <28 weeks [ Time Frame: From date of randomisation until 27 6/7 weeks ]
    Birth non-spontaneously before 28 weeks' gestation

  9. Iatrogenic preterm birth <34 weeks [ Time Frame: From date of randomisation until 33 6/7 weeks ]
    Birth non-spontaneously before 34 weeks' gestation

  10. Iatrogenic preterm birth <37 weeks [ Time Frame: From date of randomisation until 36 6/7 weeks ]
    Birth non-spontaneously before 37 weeks' gestation

  11. Onset of labor [ Time Frame: At birth ]
    Spontaneous, labor induction, elective C-section

  12. Mode of delivery [ Time Frame: At birth ]
    Vaginal delivery, C-section (elective, suspected fetal distress, non-progressive labor)

  13. Livebirth [ Time Frame: At birth ]
    The birth of at least one newborn, regardless of gestational age, that exhibits any sign of life such as respiration, heartbeat, umbilical pulsation or movement of voluntary muscles

  14. Use of tocolytic drugs [ Time Frame: From 24 0/7 to 33 6/7 weeks' gestation ]
    Use of any tocolytic drug to treat preterm labour

  15. Use of antenatal corticosteroids [ Time Frame: From 24 0/7 to 33 6/7 weeks' gestation ]
    Use of antenatal corticosteroids to prevent respiratory distressed syndrome

  16. Use of MgSO4 for neuroprotection [ Time Frame: From 28 0/7 to 31 6/7 weeks' gestation ]
    Use of MgSO4 for neuroprotection in

  17. Preterm prelabour rupture of membranes [ Time Frame: From randomization to less than 37 weeks, up to 21 weeks ]
    Prelabour rupture of membranes and gestational age less than 37 weeks

  18. Length of maternal admission for preterm labour [ Time Frame: From 24 weeks to 37 week ]
    Number of admission days for treatment of preterm labour

  19. Chorioamnionitis [ Time Frame: From randomization to delivery, up to 22 weeks ]
    Intraamniotic infection

  20. Maternal mortality [ Time Frame: From randomization to delivery, up to 22 weeks ]
    Death of the mother

  21. Birthweight [ Time Frame: At birth ]
    Weight of baby born

  22. Birthweight <1500 g [ Time Frame: At birth ]
    Weight of baby born <1500g

  23. Birthweight <2500 g [ Time Frame: At birth ]
    Weight of baby born <2500g

  24. Congenital anomalies after randomisation [ Time Frame: At birth ]
    Any congenital anomalies detected in baby born

  25. 5-min Apgar score [ Time Frame: At birth ]
    Apgar score at 5 minute after birth

  26. 5-min Apgar score <7 [ Time Frame: At birth ]
    Apgar score at 5 minute after birth <7

  27. Admission to neonatal intensive care unit (NICU) [ Time Frame: Within 7 days after birth ]
    Admission to neonatal intensive care unit of baby

  28. Length of NICU admission [ Time Frame: Up to 28 days after birth ]
    Number of admission days to NICU

  29. Respiratory distress syndrome [ Time Frame: Up to 28 days after birth ]
    The presence of tachypnoea >60/minute, sternal recession and expiratory grunting, need for supplemental oxygen, and a radiological picture of diffuse reticulogranular shadowing with an air bronchogram

  30. Periventricular haemorrhage II B or worse [ Time Frame: Up to 28 days after birth ]
    Repeated neonatal cranial ultrasound by the neonatologist according to the guidelines on neuro-imaging described by de Vries et al

  31. Necrotizing enterocolitis [ Time Frame: Up to 28 days after birth ]
    Diagnosed according to Bell

  32. Proven sepsis [ Time Frame: Up to 28 days after birth ]
    The combination of clinical signs and positive blood cultures

  33. Stillbirth [ Time Frame: At birth ]
    Baby born with no signs of life at or after 28 weeks' gestation

  34. Death before discharge [ Time Frame: Up to 28 days after birth ]
    Death of newborn before discharge from nursery

  35. Composite of poor perinatal outcomes [ Time Frame: Up to 28 days after birth ]
    Foetal or neonatal death, intraventricular haemorrhage, respiratory distress syndrome, necrotizing enterocolitis or neonatal sepsis

  36. Maternal side effects [ Time Frame: From date of randomisation until delivery, which is up to 22 weeks ]
    Including vaginal discharge, vaginal bleeding, vaginal infection (confirmed by vaginal discharge culture), vaginal pain (evaluated by VAS numerical rating scale), pessary repositioning and necrosis or rupture of the cervix, cervical laceration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with a twin pregnancy (mono- and di-chorionic)
  • 16 0/7 to 22 0/7 weeks of gestation
  • Maternal age ≥18 yrs
  • Cervical length ≤28 mm
  • Informed consent
  • Not participating in another preterm birth study at the same time

Exclusion Criteria:

  • Uterine anomalies
  • Cervical dilation with visible amniotic membranes or amniotic membranes prolapsed into the vagina
  • Twin-to-twin transfusion syndrome
  • Stillbirth or major congenital abnormalities in any of the fetus
  • Severe vaginal discharge
  • Acute vaginitis or cervicitis
  • Vaginal bleeding
  • Placental preavia
  • Vasa preavia
  • Premature rupture of membranes
  • Premature labor with/without ruptured membrane
  • Suspicion of chorioamnionitis
  • Unable to undergo cervical cerclage or pessary with or without vaginal progesterone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863613


Contacts
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Contact: Vinh Q Dang, MD +84908225481 BSVINH.DQ@MYDUCHOSPITAL.VN
Contact: Yen TN He, MD +84909309942 bsyen.htn@myduchospital.vn

Locations
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Vietnam
Dang Quang Vinh Not yet recruiting
Ho Chi Minh City, Vietnam, 9000
Contact: Dang Q Vinh    908225481    BSVINH.DQ@MYDUCHOSPITAL.VN   
Contact: Yen TH He, MD    +84909309942    bsyen.htn@myduchospital.vn   
Sponsors and Collaborators
Mỹ Đức Hospital
My Duc Phu Nhuan Hospital
Investigators
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Principal Investigator: Vinh Q Dang, MD Mỹ Đức Hospital

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Responsible Party: Mỹ Đức Hospital
ClinicalTrials.gov Identifier: NCT03863613     History of Changes
Other Study ID Numbers: CS/MD/19/01
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mỹ Đức Hospital:
Pessary, Cerclage, Progesterone, Twins, Preterm birth

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs