Vaginal Progesterone for the Prevention of Preterm Birth in Twins

Premature Birth Clinical Trial

— POPPET  

Official title:

Vaginal Progesterone for the Prevention of Preterm Birth in Twins: A Pilot Randomised, Factorial Designed Trial (POPPET)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03540225
• Other study ID #: 2016.594-T
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 2020
• Est. completion date: December 2022

Study information

• Verified date: January 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Twin Pregnancy

Intervention

Drug:
• Progesterone
Utrogestan Vaginal 200 mg or 400 mg daily from 11-14 Week or 20-24 Week until 34 Week

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Chiu Yee Liona Poon

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The median gestational age (in days) at delivery		At delivery
Secondary	The incidence of spontaneous preterm birth		Less than 34 weeks (237 days) of gestation
Secondary	Birth weight		At delivery
Secondary	Stillbirth or neonatal death due to any cause		At delivery
Secondary	Major adverse outcomes before discharge from the hospital	Intraventricular hemorrhage, respiratory distress syndrome, retinopathy of prematurity, or necrotizing entercolitis.	Within the first year
Secondary	Need for neonatal special care	Admission to a neonatal intensive care unit, ventilation, phototherapy, treatment for proven or suspected sepsis, or blood transfusion	Between birth and 28 days of age