Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies

NCT01031017 | Completed Phase 4

• 1 other identifier: 418/04
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

Twin pregnancies are at substantial increased risk of preterm delivery. Prophylactic administration of progesterone in singleton pregnancies at risk of preterm delivery has been shown to be effective in reducing the rate of such complication. The aim of this study is to investigate the effect of prophylactic administration of natural progesterone in twin pregnancies on the rate of preterm births.

Conditions

Preterm Delivery

Keywords

twin pregnancies; preterm delivery; progesterone

Outcome Measures

Primary Outcomes (1)

• gestational age at delivery

  once at the end of study

Study Arms (2)

placebo

PLACEBO COMPARATOR

group taking placebo

Drug: placebo

study group

ACTIVE COMPARATOR

group taking progesterone

Drug: progesterone

Interventions

progesterone DRUG

ovules, 200mg per vagina, once a day from 18 weeks

Also known as: utrogestan

study group

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Naturally conceived diamniotic twin pregnancies.
• Absence of major fetal abnormalities (such as neural tube defects, abdominal wall defects, cardiac defects, hydrocephalus, malformations that course with polyhydramnios) at the anomaly scan.
• Gestational age between 18 - 21+6weeks at the moment of randomization.
• Patients that are not allergic to the progesterone capsule excipients (arachis oil, soy and lecithin).
• Patients who do not use other medicines that can alter the progesterone effects, such as: barbituric, carbamazepine, hydantoin, rifampicin, betablockers, teofiline or ciclosporin.
• Porphyria, otoscleroses, malignant disease or severe depressive state.

You may not qualify if:

• Premature rupture of membranes diagnosed at the moment of recruitment.
• Subsequent diagnosis of major fetal abnormalities.
• Twin to twin transfusion syndrome diagnosed during the course of the pregnancy.
• Presence of ovular infection.
• Death of one or both fetuses in any time of the pregnancy.
• Giving up or discontinuing the use of the medication.
• Elective or iatrogenic premature birth (before 34 weeks).
• Present or past history of thromboembolic disease
• Uterine malformation
• Known or suspected breast or genitals malignancy tumor
• Plan to move to another city during pregnancy
• Placenta Previa

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital das Clinicas

São Paulo, São Paulo, 05403000, Brazil

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

• Maria Brizot, PhD

  Department of Obstetrics, São Paulo University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 14, 2009
• Study Start: June 1, 2007
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

BR (1)