Vaginal Progesterone for the Prevention of Preterm Birth in Twins

NCT03540225 | Withdrawn Phase 3

• 1 other identifier: 2016.594-T
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Premature Birth; Twin Pregnancy

Keywords

Progesterone

Outcome Measures

Primary Outcomes (1)

• The median gestational age (in days) at delivery

  At delivery

Secondary Outcomes (5)

• The incidence of spontaneous preterm birth

  Less than 34 weeks (237 days) of gestation

• Birth weight

  At delivery

• Stillbirth or neonatal death due to any cause

  At delivery

• Major adverse outcomes before discharge from the hospital

  Within the first year

• Need for neonatal special care

  Between birth and 28 days of age

Study Arms (4)

Early Low-dose Arm

EXPERIMENTAL

Start from 11-14 week: 200 mg self-administered vaginal progesterone daily

Drug: Progesterone

Early High-dose Arm

EXPERIMENTAL

Start from 11-14 week: 400 mg self-administered vaginal progesterone daily

Drug: Progesterone

Late Low-dose Arm

EXPERIMENTAL

Start from 20-24 week: 200 mg self-administered vaginal progesterone daily

Drug: Progesterone

Late High-dose Arm

EXPERIMENTAL

Start from 20-24 week: 400 mg self-administered vaginal progesterone daily

Drug: Progesterone

Interventions

Progesterone DRUG

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

Also known as: Utrogestan

Early High-dose Arm; Early Low-dose Arm; Late High-dose Arm; Late Low-dose Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiu Yee Liona Poon: lead

Study Sites (4)

Kwong Wah Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Princess Margaret Hospital

Hong Kong, Hong Kong

Location

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Progesterone; Utrogestan

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Liona CY Poon, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor (Clinical)

Model Details: 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'

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 30, 2018
• Study Start: April 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (4)