PregnancyNCT00290173
Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor
A study testing efficacy of oral ritodrine in maintaining uterine quiescence in people with Pregnancy, run by University of Zagreb at 1 site in Croatia.
Trial summary
This is a trial comparing the efficacy of oral ritodrine in the form of sustained release capsules for the maintenance of uterine quiescence after successfully treated episode of threatened preterm labor. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- efficacy of oral ritodrine in maintaining uterine quiescence
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteCroatia
- Study dates
- Start not givento Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnancy between completed 24 to 24 weeks
- Successfully treated episode of threatened preterm labour by intravenous preparations
- No uterine contractions
Who cannot join
- Uterine contractions (painful, clinically palpable, or present on cardiotocography)
- Cervical dilatation of ≥5 cm
- Clinical and laboratory signs of infection defined as offensive vaginal discharge on clinical examination, vaginal pH ≥5, white blood cell (WBC) count >16×109/L, and C-reactive protein (CRP) >10 mg/L
- Positive findings of microorganisms rather than normal vaginal flora on high vaginal swab
- Any signs of fetal distress according to cardiotocography, Doppler assessment of blood flow in umbilical artery, and biophysical profile of <8.
Trial locations and contacts
1 site in 1 country.
Croatia1 site
Department of Obstetrics and Gynecology, University of Zagreb
Zagreb, 10000
About this study
Official title: Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor: Randomized Controlled Trial
This is a trial comparing the efficacy of oral ritodrine in the form of sustained release capsules for the maintenance of uterine quiescence after successfully treated episode of threatened preterm labor.
Read the detailed description
We randomized 120 women with singleton pregnancy who were successfully treated for threatened preterm labor before 34 completed weeks to receive either maintenance tocolysis with two 40 mg ritodrine sustained release capsules three times a day (study group, n=62) or no treatment (control group, n=58) for three days. The primary outcome measure was the recurrent episode of threatened preterm labor within 72 hours, which was defined as regular palpable uterine contractions and change in cervical effacement and/or cervical dilatation on clinical examination. Secondary outcome measures included the incidence of preterm birth, neonatal adverse outcomes, and maternal side effects.
- Conditions
- Pregnancy
- Being tested
- efficacy of oral ritodrine in maintaining uterine quiescence
- Keywords
- pre term labor, therapy, maintenance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efficacy of oral ritodrine in maintaining uterine quiescenceDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
the recurrence of preterm labor within 72 hours after discontinuation of IV treatment
Secondary outcomes (1)
Secondary outcome measures were incidence of preterm delivery before 37 weeks of gestation, incidence of early preterm delivery before completed 34 weeks of gestation, prolongation of pregnancy, birth weight, perinatal mortality and perinatal morbidity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science, Education and Sport, Republic of Croatia
- Investigators
- Ozren Grgic, MD, Principal investigator, Sveti Duh HospitalRatko Matijevic, MD,PhD, Study chair, Sveti Duh Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290173
- Sponsor's protocol ID
- 0129111
- Status last verified
- Feb 2006
- First submitted
- 8 Feb 2006
- Last updated
- 4 May 2006
- Results posted
- No
Publications
Matijevic R, Grgic O, Vasilj O. Ritodrine in oral maintenance of tocolysis after active preterm labor: randomized controlled trial. Croat Med J. 2006 Feb;47(1):25-31.
PubMed 16489694
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00290173
- Acronym / sponsor ID
- 0129111
- Conditions
- Pregnancy
- Keywords
- pre term labor, therapy, maintenance
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Collaborators
- Ministry of Science, Education and Sport, Republic of Croatia
- Study completion
- Aug 2005
- First posted
- 10 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a trial comparing the efficacy of oral ritodrine in the form of sustained release capsules for the maintenance of uterine quiescence after successfully treated episode of threatened preterm labor.
Detailed description
We randomized 120 women with singleton pregnancy who were successfully treated for threatened preterm labor before 34 completed weeks to receive either maintenance tocolysis with two 40 mg ritodrine sustained release capsules three times a day (study group, n=62) or no treatment (control group, n=58) for three days. The primary outcome measure was the recurrent episode of threatened preterm labor within 72 hours, which was defined as regular palpable uterine contractions and change in cervical effacement and/or cervical dilatation on clinical examination. Secondary outcome measures included the incidence of preterm birth, neonatal adverse outcomes, and maternal side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnancy between completed 24 to 24 weeks
- Successfully treated episode of threatened preterm labour by intravenous preparations
- No uterine contractions
Key exclusion criteria (5 listed)
- Uterine contractions (painful, clinically palpable, or present on cardiotocography)
- Cervical dilatation of ≥5 cm
- Clinical and laboratory signs of infection defined as offensive vaginal discharge on clinical examination, vaginal pH ≥5, white blood cell (WBC) count >16×109/L, and C-reactive protein (CRP) >10 mg/L
- Positive findings of microorganisms rather than normal vaginal flora on high vaginal swab
- Any signs of fetal distress according to cardiotocography, Doppler assessment of blood flow in umbilical artery, and biophysical profile of <8.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| efficacy of oral ritodrine in maintaining uterine quiescence | Drug | – |
Primary outcome
the recurrence of preterm labor within 72 hours after discontinuation of IV treatment
1 secondary outcome
Secondary outcome measures were incidence of preterm delivery before 37 weeks of gestation, incidence of early preterm delivery before completed 34 weeks of gestation, prolongation of pregnancy, birth weight, perinatal mortality and perinatal morbidity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2006.
- Results publication: PubMed 16489694Matijevic R, Grgic O, Vasilj O. Ritodrine in oral maintenance of tocolysis after active preterm labor: randomized controlled trial. Croat Med J. 2006 Feb;47(1):25-31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozren Grgic, MD principal investigator
Sveti Duh Hospital
Ratko Matijevic, MD,PhD study chair
Sveti Duh Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing efficacy of oral ritodrine in maintaining uterine quiescence in people with Pregnancy, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the recurrence of preterm labor within 72 hours after discontinuation of IV treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00290173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2006.