Labor, PrematurePhase 4NCT00599898
Nifedipine Compared to Atosiban for Treating Preterm Labor
A Phase 4 study testing Atosiban and Nifedipine in people with Labor, Premature, run by Raed Salim at 1 site in Israel.
Trial summary
The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Labor, Premature
- What is being tested?
- Atosiban and Nifedipine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Feb 2012
- Phase
- Phase 4
- 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
- Gestational age between 24 to 34 weeks which had been documented by a definite LMP and sonography up to 20 weeks.
- All women fulfilled the criteria of preterm labor. The diagnosis of preterm labor required the presence of 4 uterine contractions or more over 30 minutes, each lasting at least 30 seconds, and documented cervical change. The cervical criteria were met when either of the following was present:
- Nulliparous women: a single cervical examination demonstrating dilatation of 0 cm to 4 cm and effacement of at least 50%
- Multiparous women: a single cervical examination demonstrating dilatation of 1 cm to 4 cm and effacement of at least 50%.
- Provision of written informed consent
Who cannot join
- Chorioamnionitis
- Preterm rupture of membranes
- Vaginal bleeding
- Major fetal malformations
- Severe hypertensive disorders
- Intrauterine growth restriction (< 5th percentile).
Show all 13Show fewer
- Non-reassuring fetal heart rate
- Maternal contraindications
- Chronic hypertension
- Systolic blood pressure < 90 mmHg
- Cardiovascular disease
- Elevated hepatic enzymes
- Congenital or acquired uterine malformation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.
The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor.
- Conditions
- Labor, Premature
- Being tested
- Atosiban, Nifedipine
- Keywords
- Preterm labor, Atosiban, Nifedipine
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtosibanDrug
Atosiban group will receive an atosiban bolus (6.75 mg) over 1 min then an intravenous infusion of 300mcg/min for 3 h followed by 100mcg/min for another 45h. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, atosiban will be stopped and the women will receive nifedipine as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.
NifedipineDrug
Nifedipine group: the initial dose will be 20 mg (one tab) orally every 20 min for 3 doses. If the contractions is inhibited, a maintenance dose of 20 - 40 mg every 6 h up to 48 h will be followed. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, nifedipine will be stopped and the women will receive atosiban as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Atosiban |
| 2 | Experimental | Not described Receives: Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
delaying labor
Measured: for more than 48 hours after starting treatment
Secondary outcomes (3)
drugs side effects
Measured: within the first 48 hours after treatment
obstetrical (number of days to delivery, gestational age at delivery, mode of delivery)
Measured: within 24 hours after delivery
neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH)
Measured: within 30 days from delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Labor, PrematureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raed Salim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raed Salim, HaEmek Medical Center, Israel
- Investigators
- Gali Garmi, MD, Principal investigator, HaEmek Medical Center, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599898
- Sponsor's protocol ID
- EMC070048CTIL
- Other IDs
- same as unique protocol ID
- Status last verified
- Mar 2012
- First submitted
- 8 Jan 2008
- Last updated
- 13 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
King JF, Flenady V, Papatsonis D, Dekker G, Carbonne B. Calcium channel blockers for inhibiting preterm labour; a systematic review of the evidence and a protocol for administration of nifedipine. Aust N Z J Obstet Gynaecol. 2003 Jun;43(3):192-8. doi: 10.1046/j.0004-8666.2003.00074.x.
PubMed 14712983Papatsonis DN, Van Geijn HP, Ader HJ, Lange FM, Bleker OP, Dekker GA. Nifedipine and ritodrine in the management of preterm labor: a randomized multicenter trial. Obstet Gynecol. 1997 Aug;90(2):230-4. doi: 10.1016/S0029-7844(97)00182-8.
PubMed 9241299Moutquin JM, Sherman D, Cohen H, Mohide PT, Hochner-Celnikier D, Fejgin M, Liston RM, Dansereau J, Mazor M, Shalev E, Boucher M, Glezerman M, Zimmer EZ, Rabinovici J. Double-blind, randomized, controlled trial of atosiban and ritodrine in the treatment of preterm labor: a multicenter effectiveness and safety study. Am J Obstet Gynecol. 2000 May;182(5):1191-9. doi: 10.1067/mob.2000.104950.
PubMed 10819857Wilson 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 35947046Salim R, Garmi G, Nachum Z, Zafran N, Baram S, Shalev E. Nifedipine compared with atosiban for treating preterm labor: a randomized controlled trial. Obstet Gynecol. 2012 Dec;120(6):1323-31. doi: 10.1097/aog.0b013e3182755dff.
PubMed 23168756
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00599898
- Acronym / sponsor ID
- EMC070048CTIL
- Conditions
- Labor, Premature
- Keywords
- Preterm labor, Atosiban, Nifedipine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Raed SalimUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 24 Jan 2008 (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.
The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Atosiban |
| 2 | Experimental | Drug: Nifedipine |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Gestational age between 24 to 34 weeks which had been documented by a definite LMP and sonography up to 20 weeks.
- All women fulfilled the criteria of preterm labor. The diagnosis of preterm labor required the presence of 4 uterine contractions or more over 30 minutes, each lasting at least 30 seconds, and documented cervical change. The cervical criteria were met when either of the following was present:
- Provision of written informed consent
Key exclusion criteria (13 listed)
- Chorioamnionitis
- Preterm rupture of membranes
- Vaginal bleeding
- Major fetal malformations
- Severe hypertensive disorders
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 |
|---|---|---|
| AtosibanAtosiban group will receive an atosiban bolus (6.75 mg) over 1 min then an intravenous infusion of 300mcg/min for 3 h followed by 100mcg/min for another 45h. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, atosiban will be stopped and the women will receive nifedipine as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line. | Drug | 1 |
| NifedipineNifedipine group: the initial dose will be 20 mg (one tab) orally every 20 min for 3 doses. If the contractions is inhibited, a maintenance dose of 20 - 40 mg every 6 h up to 48 h will be followed. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, nifedipine will be stopped and the women will receive atosiban as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line. | Drug | 2 |
Primary outcome
delaying labor
Time frame: for more than 48 hours after starting treatment
3 secondary outcomes
drugs side effects
Time frame: within the first 48 hours after treatment
obstetrical (number of days to delivery, gestational age at delivery, mode of delivery)
Time frame: within 24 hours after delivery
neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH)
Time frame: within 30 days from delivery
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 13 Mar 2012.
- Background: PubMed 14712983King JF, Flenady V, Papatsonis D, Dekker G, Carbonne B. Calcium channel blockers for inhibiting preterm labour; a systematic review of the evidence and a protocol for administration of nifedipine. Aust N Z J Obstet Gynaecol. 2003 Jun;43(3):192-8. doi: 10.1046/j.0004-8666.2003.00074.x.
- Background: PubMed 9241299Papatsonis DN, Van Geijn HP, Ader HJ, Lange FM, Bleker OP, Dekker GA. Nifedipine and ritodrine in the management of preterm labor: a randomized multicenter trial. Obstet Gynecol. 1997 Aug;90(2):230-4. doi: 10.1016/S0029-7844(97)00182-8.
- Background: PubMed 10819857Moutquin JM, Sherman D, Cohen H, Mohide PT, Hochner-Celnikier D, Fejgin M, Liston RM, Dansereau J, Mazor M, Shalev E, Boucher M, Glezerman M, Zimmer EZ, Rabinovici J. Double-blind, randomized, controlled trial of atosiban and ritodrine in the treatment of preterm labor: a multicenter effectiveness and safety study. Am J Obstet Gynecol. 2000 May;182(5):1191-9. doi: 10.1067/mob.2000.104950.
- Derived from this study: PubMed 35947046Wilson 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.
- Derived from this study: PubMed 23168756Salim R, Garmi G, Nachum Z, Zafran N, Baram S, Shalev E. Nifedipine compared with atosiban for treating preterm labor: a randomized controlled trial. Obstet Gynecol. 2012 Dec;120(6):1323-31. doi: 10.1097/aog.0b013e3182755dff.
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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.
Gali Garmi, MD principal investigator
HaEmek Medical Center, Afula, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atosiban and Nifedipine in people with Labor, Premature, run by Raed Salim at 1 site in Israel.
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 5 inclusion and 13 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 13 Mar 2012. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
delaying labor (time frame: for more than 48 hours after starting 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 NCT00599898, which also lists 5 linked publications.
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 13 Mar 2012.