NCT00295464

Brief Summary

Administration of steroid to the mother in imminent preterm delivery is a known effective practice to decrease the risk of respiratory distress syndrome and intraventricular haemorrhage in preterm infants if given with a week of the preterm delivery. This randomized clinical trial is performed to test the possibility whether the repeat dose of steroid results in further reduction of these diseases in case the mother is in imminent preterm delivery more than a week after the first antenatal steroid treatment.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2006

Completed
Last Updated

May 3, 2006

Status Verified

February 1, 2006

First QC Date

February 21, 2006

Last Update Submit

May 1, 2006

Conditions

Respiratory Distress SyndromeIntraventricular Haemorrhage

Keywords

Antenatal glucocorticoidPremature birth

Outcome Measures

Primary Outcomes (2)

  • Intact survival without RDS and/or severe (gr 3-4) ICH

  • Follow-up study at corrected age of two years

Secondary Outcomes (2)

  • A number of diseases in preterm infants

  • Number of mothers with premature delivery

Interventions

Betamethasone sodium phos (drug)DRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The pregnant women will be eligible for the trial entry if all following criteria are met:
  • administration of a course of antenatal corticosteroid at least 7 days before the trial entry
  • gestational age is less than 33.0 weeks 6 days\*
  • very high risk of premature delivery\*\*
  • none of the following therapies complications or therapies maternal long term systemic corticosteroid therapy severe clinical chorioamnionitis (maternal fever, increased CRP or another acute phase protein, uterine tenderness) lethal disease of the fetus
  • informed consent obtained
  • premature rupture of membranes is not contraindication for the trial entry
  • \*Gestational age will be calculated from the mother's last menstrual period and confirmed by ultrasound before 20 weeks' gestation. In case the discrepancy in the estimates exceeds two weeks, ultrasound date is accepted.
  • \*\*Very high risk of premature delivery is described as follows:
  • elective delivery within within 4-48 hours, as indicated by the obstetrician on the basis of the clinical status of the mother and/or the fetus
  • very high risk of spontaneous delivery within 4-48 hours, i.e.
  • cervix is open \> 3 cm
  • contractions of the uterus at 5-10 min intervals
  • rupture of the membranes after the first course of ANC
  • fetal and/or maternal indication for elective premature delivery or cesarean section

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Helsinki University Central Hospital, Finland

Helsinki, 00029 HUS, Finland

Location

Joensuu Central Hospital

Joensuu, Finland

Location

Jyväskylä Central Hospital

Jyväskylä, Finland

Location

Kuopio University Central Hospital

Kuopio, Finland

Location

Lahti Central Hospital

Lahti, Finland

Location

Oulu University Hospital

Oulu, 90029 OYS, Finland

Location

Central Hospital of Pori

Pori, Finland

Location

Seinäjoki Central Hospital

Seinäjoki, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Turku Central Hospital

Turku, Finland

Location

Related Publications (1)

  • Pesonen AK, Raikkonen K, Lano A, Peltoniemi O, Hallman M, Kari MA. Antenatal betamethasone and fetal growth in prematurely born children: implications for temperament traits at the age of 2 years. Pediatrics. 2009 Jan;123(1):e31-7. doi: 10.1542/peds.2008-1809. Epub 2008 Dec 15.

    PMID: 19074961DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromePremature Birth

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Mikko N Hallman, MD

    Children's Hospital, Univ. of Oulu

    STUDY DIRECTOR

  • Outi M Peltoniemi, MD

    Children's Hospital, Univ. of Oulu

    PRINCIPAL INVESTIGATOR

  • Pentti Jouppila, MD

    Oulu Central Hospital, Dept. of Obstetrics & Gynecology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 23, 2006

Study Start

May 1, 2001

Last Updated

May 3, 2006

Record last verified: 2006-02

Locations

FI(10)