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Vaginal Progesterone for the Prevention of Preterm Birth in Twins (POPPET)

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ClinicalTrials.gov Identifier: NCT03540225
Recruitment Status : Withdrawn (Fail to sort out the logistics of study drugs due to funding problems)
First Posted : May 30, 2018
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Chiu Yee Liona Poon, Chinese University of Hong Kong

Brief Summary:
This trial is a randomised, multi-centre, 2 x 2 factorial designed pilot trial with two factors of 200mg vs. 400mg progesterone self-administered daily from 11-14 weeks' gestation vs. 20-24 weeks' gestation, to compare the median gestational age (in days) at delivery between the comparison groups.

Condition or disease Intervention/treatment Phase
Premature Birth Twin Pregnancy Drug: Progesterone Phase 3

Detailed Description:

Randomised studies in singleton pregnancies suggest that the risk of preterm birth can be decreased by using of progesterone. However, in twin pregnancies, no significant reduction in preterm birth has been demonstrated in any trial.

One explanation for the lack of benefit of progesterone in previous twin studies may result from a suboptimal dosage. The investigators therefore hypothesize that progesterone dosages that are sufficient for singleton pregnancies are insufficient for twins and this is likely to be one of the reasons why prophylactic progesterone has failed to reduce preterm birth in twins.

Another possible explanation for the negative findings in previous twin studies may result from administration beginning too late in the second-trimester. It is thought that the mechanism of preterm birth in twin pregnancies is more strongly related to exaggerated uterine distension, which may override any benefit of progesterone on the cervix after a threshold has been reached. It is also plausible that cervical shortening occurs earlier in twin pregnancies than with singletons, and that treatment is required before a threshold of shortening is reached or before any inflammation-mediated component to the initiation of preterm birth has been established as the biological mechanisms by which preterm birth occurs differ from those in singleton pregnancies.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2 x 2 factorial designed trial with two factors of 200mg vs. 400mg vaginal progesterone daily from 11-14 weeks' gestation vs. 20-24 weeks'
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Vaginal Progesterone for the Prevention of Preterm Birth in Twins: A Pilot Randomised, Factorial Designed Trial (POPPET)
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early Low-dose Arm
Start from 11-14 week: 200 mg self-administered vaginal progesterone daily
Drug: Progesterone
Utrogestan Vaginal 200 mg or 400 mg daily from 11-14 Week or 20-24 Week until 34 Week
Other Name: Utrogestan

Experimental: Early High-dose Arm
Start from 11-14 week: 400 mg self-administered vaginal progesterone daily
Drug: Progesterone
Utrogestan Vaginal 200 mg or 400 mg daily from 11-14 Week or 20-24 Week until 34 Week
Other Name: Utrogestan

Experimental: Late Low-dose Arm
Start from 20-24 week: 200 mg self-administered vaginal progesterone daily
Drug: Progesterone
Utrogestan Vaginal 200 mg or 400 mg daily from 11-14 Week or 20-24 Week until 34 Week
Other Name: Utrogestan

Experimental: Late High-dose Arm
Start from 20-24 week: 400 mg self-administered vaginal progesterone daily
Drug: Progesterone
Utrogestan Vaginal 200 mg or 400 mg daily from 11-14 Week or 20-24 Week until 34 Week
Other Name: Utrogestan




Primary Outcome Measures :
  1. The median gestational age (in days) at delivery [ Time Frame: At delivery ]

Secondary Outcome Measures :
  1. The incidence of spontaneous preterm birth [ Time Frame: Less than 34 weeks (237 days) of gestation ]
  2. Birth weight [ Time Frame: At delivery ]
  3. Stillbirth or neonatal death due to any cause [ Time Frame: At delivery ]
  4. Major adverse outcomes before discharge from the hospital [ Time Frame: Within the first year ]
    Intraventricular hemorrhage, respiratory distress syndrome, retinopathy of prematurity, or necrotizing entercolitis.

  5. Need for neonatal special care [ Time Frame: Between birth and 28 days of age ]
    Admission to a neonatal intensive care unit, ventilation, phototherapy, treatment for proven or suspected sepsis, or blood transfusion



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Dichorionic diamniotic (DCDA) pregnancies
  • Live fetuses at 11-13 weeks of gestation,
  • Informed and written consent

Exclusion Criteria:

  • High-risk for aneuploidies,
  • Pregnancies complicated by major fetal abnormality identified at the 11-13 weeks or 20-24 weeks assessment,
  • Hypersensitivity to progesterone,
  • Women taking progesterone regularly or at any time within the previous 7 days,
  • Concurrent participation in another drug trial or at any time within the previous 28 days,
  • Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness,
  • Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.

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): NCT03540225


Locations
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Hong Kong
Kwong Wah Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Chiu Yee Liona Poon
Investigators
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Principal Investigator: Liona CY Poon, MD Chinese University of Hong Kong
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Responsible Party: Chiu Yee Liona Poon, Associate Professor (Clinical), Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03540225    
Other Study ID Numbers: 2016.594-T
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Chiu Yee Liona Poon, Chinese University of Hong Kong:
Progesterone
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