Preterm LaborPhase 2UTROGESTANNCT01985594
Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial
A Phase 2 study testing utrogestan and Nifedipine in people with Preterm Labor, run by nor zila hassan malek at 1 site in Malaysia.
Trial summary
RESEARCH HYPOTHESIS -Incidence of preterm delivery is lower in women treated with oral micronized progesterone (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side effect Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Labor
- What is being tested?
- utrogestan and Nifedipine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteMalaysia
- Study dates
- Nov 2013to Oct 2014
- Phase
- Phase 2
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy women between 22 and 34 weeks of gestation who presented with threatened preterm labor.
Who cannot join
- Multiple pregnancies
- Women with Preterm Prelabour Rupture of Membrane
- Fetal death
- Women with bad obstetric history
- Women with history of cervical incompetence
- Contraindication to Nifedipine such as cardiovascular disease, hyperthyroidism, severe pre eclampsia or to Utrogestan
Show all 11Show fewer
- Maternal or fetal indication for immediate delivery, such as fetal distress, bleeding placenta previa, abruption placenta
- Contraindication for tocolysis, for example severe pre eclampsia, intrauterine growth restriction, fetal anomaly, chorioamnionitis, significant antepartum haemorrhage
- Cervical dilatation of 3cm or more
- Patients with previous tocolytic treatment during this pregnancy
- Women who refuse to participate in this study
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Obstetric and Gynaecology Department, National University of Malaysia Medical Centre
Cheras, Kuala Lumpur, 56000
national university of malaysia medical centre, 60391455950
nor zila hassan malek
About this study
Official title: STUDY ON EFFICACY OF UTROGESTAN AS TOCOLYSIS FOR PRETERM LABOR
RESEARCH HYPOTHESIS
-Incidence of preterm delivery is lower in women treated with oral micronized progesterone (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side effect
- Conditions
- Preterm Labor
- Being tested
- utrogestan, Nifedipine
- Keywords
- preterm labor
- 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.
utrogestanDrug
Oral Tablet Utrogestan 400 mg daily for 2 days
NifedipineDrug
Tablet Nifedipine 20 mg stat then 20 mg after 30 minutes if contraction persist and another 20mg after 30 minutes if contraction still persist followed by 10 mg three times daily for 2 days
| Study group | Role | What they receive |
|---|---|---|
| Utrogestan | Active comparator | oral tablet Utrogestan 400mg daily for 2 days Receives: Drug: utrogestan |
| Nifedipine | Placebo comparator | tablet Nifedipine 20 mg stat then 20 mg after 30 minutes then another 20 mg after 30 minutes followed by 10 mg three times daily for 2 days Receives: Drug: Nifedipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
latency period interval between time of tocolysis and delivery
delivery less than 24 hours of tocolysis,delivery less than 48 hours of tocolysis, delivery less than 7 days of tocolysis
Measured: 24 hours up to 7 days
Secondary outcomes (3)
Pregnancy outcomes
delivery less than 34 weeks of gestation, delivery more than or at 34 weeks of gestation
Measured: 34 weeks of gestational age
Neonatal outcome
Birth weight (kg),cord blood acidity, need for neonatal intensive care unit admission
Measured: 24 hours
Maternal side effect
Palpitation,Headache, Nausea/Vomiting, Hypotension, Dyspnea, Jaundice, Pruritus
Measured: 30 minutes up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2014 (estimated)
- Study completionOct 2014 (estimated)
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 Preterm LaborStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- nor zila hassan malek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, nor zila hassan malek, National University of Malaysia
- Investigators
- nor azlin mohamed ismail, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985594
- Sponsor's protocol ID
- FF-2013-407
- Acronym
- UTROGESTAN
- Status last verified
- Nov 2013
- First submitted
- 4 Nov 2013
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY ON EFFICACY OF UTROGESTAN AS TOCOLYSIS FOR PRETERM LABOR
- ClinicalTrials.gov ID
- NCT01985594
- Acronym / sponsor ID
- UTROGESTAN / FF-2013-407
- Conditions
- Preterm Labor
- Keywords
- preterm labor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- nor zila hassan malekUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 15 Nov 2013 (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.
RESEARCH HYPOTHESIS
-Incidence of preterm delivery is lower in women treated with oral micronized progesterone (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side effect
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Utrogestan | Active comparator | Drug: utrogestanoral tablet Utrogestan 400mg daily for 2 days |
| Nifedipine | Placebo comparator | Drug: Nifedipinetablet Nifedipine 20 mg stat then 20 mg after 30 minutes then another 20 mg after 30 minutes followed by 10 mg three times daily for 2 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Singleton pregnancy women between 22 and 34 weeks of gestation who presented with threatened preterm labor.
Key exclusion criteria (11 listed)
- Multiple pregnancies
- Women with Preterm Prelabour Rupture of Membrane
- Fetal death
- Women with bad obstetric history
- Women with history of cervical incompetence
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 |
|---|---|---|
| utrogestanOral Tablet Utrogestan 400 mg daily for 2 days | Drug | Utrogestan |
| NifedipineTablet Nifedipine 20 mg stat then 20 mg after 30 minutes if contraction persist and another 20mg after 30 minutes if contraction still persist followed by 10 mg three times daily for 2 days | Drug | Nifedipine |
Primary outcome
latency period interval between time of tocolysis and delivery
Time frame: 24 hours up to 7 days
delivery less than 24 hours of tocolysis,delivery less than 48 hours of tocolysis, delivery less than 7 days of tocolysis
3 secondary outcomes
Pregnancy outcomes
Time frame: 34 weeks of gestational age
Neonatal outcome
Time frame: 24 hours
Maternal side effect
Time frame: 30 minutes up to 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
- 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.
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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.
nor azlin mohamed ismail principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing utrogestan and Nifedipine in people with Preterm Labor, run by nor zila hassan malek at 1 site in Malaysia.
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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 15 Nov 2013. 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 Malaysia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nor zila hassan malek (60139823219, nzhm_dr@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
latency period interval between time of tocolysis and delivery (time frame: 24 hours up to 7 days). 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 NCT01985594, 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 15 Nov 2013.