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Threatened Preterm LaborPhase 3NCT01314859

Nifedipine Treatment in Preterm Labor

A Phase 3 study testing Nifedipine and Atosiban in people with Threatened Preterm Labor, run by Hospital Clinico Universitario de Santiago.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a study for pregnant women who have been diagnosed with Threatened Preterm Labor. The principal aim of this study is to compare the efficacy and safety of Nifedipine treatment versus Atosiban treatment over these patients' newborn babies. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Threatened Preterm Labor
What is being tested?
Nifedipine and Atosiban
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jul 2011to Jul 2013
Phase
Phase 3
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The study population and the inclusion criteria is established by patients between the 24th and 33+6th weeks of pregnancy, fixed by an ecography during the first three-month period, and with a threat of preterm labor (TLP), by the American College of Obstetricians and Gynecologists (ACOG's) criteria:
  • Four contractions or more with a duration of at least 30 seconds during 30 minutes
  • Documented cervix changes:
  • The cervix changes in a nulliparous woman are: both cervix tact with 0 to 4 cm of dilatation and cervical effacement of at least a 50% (vaginal ultrasound alternative with cervix length two standard curvatures under the average for the gestational age)
  • The cervix changes in a multiparous woman are: 1 to 4 cm of dilatation and cervical effacement of at least a 50% (same ecographic alternative as the nulliparous).
  • Patient who had signed the informed consent.

Who cannot join

  • Exclusion criteria of the pregnant mother and intrauterine fetal:
  • Prior treatment with a different tocolytic from the ones in the protocol.
  • Chorioamnionitis.
  • Premature rupture of membranes.
  • Vaginal Bleeding.
  • Major fetal malformations.
Show all 18Show fewer
  • Intrauterine growth retardation (IGR): IGR<percentile 5.
  • Cardiopathies (aortic stenosis, congestive heart failure).
  • Blood Pressure lower than 100/60 mmHg.
  • High transaminase levels.
  • Uterine malformations.
  • Use of magnesium sulphate.
  • Severe hypertensive disorder, defined as blood pressure equal to or greater than 160/100 mmHg or any figure associated with severe preeclampsia.
  • Non-reassuring cardiac frequency tracing defined as category II and III of National Institute of Child Health and Human Development (NICHD).
  • Asthmatic patients treated with betamimetics.
  • Hypertensive patients treated with vasodilators.
  • Patient in treatment or treated with another product/s in investigation during the four weeks prior to randomization.
  • Hypersensitivity to any drug of the study.

About this study

Official title: ADMINISTRATION OF NIFIDEPINE VERSUS ATOSIBAN IN PREGNANT WOMEN WITH A THREAT OF PREMATURE LABOR

This is a study for pregnant women who have been diagnosed with Threatened Preterm Labor. The principal aim of this study is to compare the efficacy and safety of Nifedipine treatment versus Atosiban treatment over these patients' newborn babies.

Read the detailed description

Preterm labor is defined as the presence of uterine contractions of sufficient frequency and intensity to effect progressive effacement and dilation of the cervix prior to term gestation (between 20 and 37 weeks).

It is a major health problem of increased incidence, affecting approximately between 7-10% of pregnant women in developed countries with a high socioeconomic costs and high rates of fetal mortality, although perinatal progress.

This study may allow to establish the existence of differences in perinatal outcomes and to define the first choice drug for tocolysis.

Being tested
Nifedipine, Atosiban
Keywords
Nifedipine, Obstetric Labor, Premature, Tocolysis
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NifedipineDrug

    • Oral Treatment with Nifedipine capsules (10mg)
    • Initial dose: 20 mg of nifedipine (2 capsules of 10 mg).
    • Maintenance Dose: 20 mg of nifedipine (2 capsules of 10 mg) every 6 hours.
    • Maximum Duration of the treatment: 48 hours.

  • AtosibanDrug

    • Intravenously Treatment with Atosiban (7.5mg/ml)
    • Initial Dose: IV bolus injection during 1 minute + Intravenous infusion 7.5 mg/ml during 3 hours.
    • Maintenance: Maintenance intravenous infusion 7.5 mg/ml at least 18 hours to a maximum of 45 hours.
    • Maximum Duration of the treatment: 48 hours.
Study groups in NCT01314859
Study groupRoleWhat they receive
NifedipineExperimental* Oral Treatment with Nifedipine capsules (10 mg) * Initial dose: 20 mg of nifedipine (2 capsules of 10 mg). * Maintenance Dose: 20 mg of nifedipine (2 capsules of 10 mg) every 6 hours. * Maximum Duration of the treatment: 48 hours.
Receives: Drug: Nifedipine
AtosibanActive comparator* Intravenously Treatment with Atosiban (7.5mg/ml) * Initial Dose: IV bolus injection during 1 minute + Intravenous infusion 7.5 mg/ml during 3 hours. * Maintenance: Maintenance intravenous infusion 7.5 mg/ml at least 18 hours to a maximum of 45 hours. * Maximum Duration of the treatment: 48 hours.
Receives: Drug: Atosiban

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Neonatal Respiratory Distress Syndrome (RDS) at birth

    • Clinical assessment: results of the Silverman test. Existence of tachypnea, chest wall retractions, auricular flutter, expiratory grunting and chest-abdominal asynchrony.
    • Need of 02 at birth (maximum Fi02 in the first 24 hours to estimate the immediate distress). Measurement of pCO2 at birth.
    • Need of mechanic ventilation: invasive/not invasive and duration of it.
    • Radiologic estimation of the level of hyaline membrane disease
    • Need of a surfactant and number of used dosages.

    Measured: Measured in the newborn at birth and at 30 days after labor

Secondary outcomes (7)

  1. Prolongation of the pregnancy in women with Threatened Preterm Labor

    It will be evaluated as a delay in the labor: hours after starting the treatment: more than 48 hours/more than 7 days of prolongation.

    Measured: more than 48 hours/7 days

  2. Obstetric results

    Number of days and type of labor.

    Measured: at labor and 24 hours after delivery

  3. Presence of the neonatal intracranial hemorrhage

    Determination of the appearance and periventricular hemorrhage degree (I-IV) by transfontelar ultrasound scans.

    Measured: First assessment: in the first week.

  4. Presence of neonatal necrotizing enterocolitis

    Monitor the need of canalizing the umbilical vein or artery, the days of parenteral nutrition, days to the start of enteral nutrition, type of enteral nutrition (from the mother, artificial or mixed), start of the elimination of meconium, clinical data from the neonatal necrotizing enterocolitis(abdominal strain, vomiting, blood in the feces, septic appearance) and radiologic/ecographic (dilated bowel loops, intestinal pneumatosis, air in portal, pneumoperitoneum).

    Measured: at birth and at 30 days after labor

  5. Presence of Retinopathy of prematurity (ROP)

    Monitor the iGF1 (Insulin-like growth factor 1) levels on the 3rd week of life as well as an assessing the development of retinopathy.

    Measured: Between the 4th and 6th week of baby life.

  6. Presence of ductus

    Clinical assessment (heart murmur, jumpy pulse, worsening of the clinical basal situation), echocardiography (confirmation of the ductus, Al/Ao relation, ductal size), medical or surgical treatment necessity.

    Measured: At birth and 30 days after labor

  7. Mother Tolerance Results

    Survey to assess the tolerance to the symptomatology induced by the medicines (flush, tachycardia, digestive upsets).

    Measured: at labor and 24 hours after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionJul 2012 (estimated)
  4. Study completionJul 2013 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01314859
Sponsor's protocol ID
MMC-NIF-2010-01
Other IDs
2010-024122-37
Status last verified
Feb 2011
First submitted
14 Mar 2011
Last updated
29 Jul 2014
Results posted
No

Publications

  • Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.

    PubMed 35947046

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nifedipine and Atosiban in people with Threatened Preterm Labor, run by Hospital Clinico Universitario de Santiago.

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 6 inclusion and 18 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: withdrawn, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Neonatal Respiratory Distress Syndrome (RDS) at birth (time frame: Measured in the newborn at birth and at 30 days after labor). 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 NCT01314859, 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 29 Jul 2014.

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