Nifedipine Treatment in Preterm Labor

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Primary Purpose

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Nifedipine

Atosiban

About this trial

This is an interventional treatment trial for Threatened Preterm Labor focused on measuring Nifedipine, Obstetric Labor, Premature, Tocolysis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nifedipine

Atosiban

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Obstetric results

Number of days and type of labor.

Presence of the neonatal intracranial hemorrhage

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

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).

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.

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.

Mother Tolerance Results

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

Full Information

NCT ID

NCT01314859

First Posted

March 14, 2011

Last Updated

July 28, 2014

Sponsor

Hospital Clinico Universitario de Santiago

Collaborators

Fundación Ramón Domínguez

1. Study Identification

Unique Protocol Identification Number

NCT01314859

Brief Title

Nifedipine Treatment in Preterm Labor

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Withdrawn

Study Start Date

July 2011 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

July 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Clinico Universitario de Santiago

Collaborators

Fundación Ramón Domínguez

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Threatened Preterm Labor

Keywords

Nifedipine, Obstetric Labor, Premature, Tocolysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nifedipine

Arm Type

Experimental

Arm Description

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.

Arm Title

Atosiban

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Nifedipine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Atosiban

Intervention Description

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.

Primary Outcome Measure Information:

Title

Neonatal Respiratory Distress Syndrome (RDS) at birth

Description

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.

Time Frame

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

Secondary Outcome Measure Information:

Title

Prolongation of the pregnancy in women with Threatened Preterm Labor

Description

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.

Time Frame

more than 48 hours/7 days

Title

Obstetric results

Description

Number of days and type of labor.

Time Frame

at labor and 24 hours after delivery

Title

Presence of the neonatal intracranial hemorrhage

Description

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

Time Frame

First assessment: in the first week.

Title

Presence of neonatal necrotizing enterocolitis

Description

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).

Time Frame

at birth and at 30 days after labor

Title

Presence of Retinopathy of prematurity (ROP)

Description

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

Time Frame

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

Title

Presence of ductus

Description

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.

Time Frame

At birth and 30 days after labor

Title

Mother Tolerance Results

Description

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

Time Frame

at labor and 24 hours after delivery

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials: