Preterm Labor With Intact MembranesPhase 2INDOGESTNCT01577121
Evaluation of the Use of Indomethacin as Co-treatment in Women With Preterm Labor and High Risk of Intraamniotic Inflammation
A Phase 2 study testing indomethacin in people with Preterm Labor With Intact Membranes, run by Sara Varea at 1 site in Spain.
Trial summary
To demonstrate if indomethacin associated to conventional treatment for preterm labor is useful to delay delivery and to improve neonatal morbimortality in women with preterm labor with high risk of intraamniotic inflammation Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Labor With Intact Membranes
- What is being tested?
- indomethacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2012to Sep 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant women with preterm labor admitted to hospital and treated with tocolysis
- pregnant women less than 28.0 and those women from 28.0 to 32.0 with a sonographic cervical length < 15 mm
- single pregnancy
- normal amniotic fluid
- normal arterial ductus
Who cannot join
- Age below 18 years
- previous use of indomethacin in the index pregnancy
- chorioamnionitis, preterm prelabour rupture of membranes or those fetal or maternal pathologies which could be responsible of an iatrogenic preterm delivery.
- oligohydramnios
- allergy to NSAID
- previous history of gastrointestinal bleeding
- use of NSAID contraindicated
- not adherence to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Utility of Indomethacin as Support Treatment in Women With Preterm Labor With Intact Membranes and High Risk of Intraamniotic Inflammation
To demonstrate if indomethacin associated to conventional treatment for preterm labor is useful to delay delivery and to improve neonatal morbimortality in women with preterm labor with high risk of intraamniotic inflammation
Read the detailed description
Randomised patients would be assigned to receive indomethacin either placebo oral use(50 mg every 6 hours during 5 days) to evaluate the efficacy of indomethacin as complementary treatment to increase the gestational age at delivery in women admitted with preterm labor and intact membranes with high risk of intraamniotic inflammation, defined as a gestational age at admission less than 28.0 weeks or those women from 28-32.0 weeks with a sonographic cervical length less than 15 mm
- Conditions
- Preterm Labor With Intact Membranes
- Being tested
- indomethacin, placebo
- 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.
indomethacinDrug
50 mg / 6 hours during 5 days
placeboDrug
50 mg / 6 hours during 5 days
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| indomethacin | Experimental | 50 mg/ 6 hours of indomethacin oral use Receives: Drug: indomethacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at delivery
number of weeks and days at delivery
Measured: before than 42 weeks of gestation
Secondary outcomes (7)
proportion of patients with spontaneous preterm delivery before 34 weeks of gestation
the participants will be followed until delivery. The proportion of patiens with spontaneous preterm delivery before week 34 will be available at the end of the study, once the last patient delivers.
Measured: at the end of study (maximum 1 year)
Incidence of adverse events
adverse events will be registered
Measured: 1 year (end of study)
Latency from admission to delivery
Latency from admission to delivery will be calculated
Measured: between initial admission and delivery (before 42 weeks of gestation)
IL-6 levels in amniotic fluid and umbilical cord blood
the investigators will determine the level of IL-6 in different samples
Measured: delivery (maximum 42 weeks of gestational age)
Number of emergency visits
Number of visits to emergency area will be registered
Measured: between initial admission and delivery (before 42 weeks of gestation)
Neonatal morbidity
neonatal morbidity will be registered:
- admission to Neonatal Intensive Care Unit (NICU)
- number of days of NICU admission
- respiratory distress syndrome
- intraventricular haemorrage
- early onset neonatal sepsis
- necrotizing enterocolitis
- late neonatal sepsis
- neonatal death.
Measured: at the end of the study (1 year)
Neonatal death
Neonatal deaths will be registered
Measured: at the end of the study (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2014
- Study completionSep 2014
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 Labor With Intact MembranesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Varea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Varea, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577121
- Sponsor's protocol ID
- INDOGEST
- Acronym
- INDOGEST
- Status last verified
- Oct 2014
- First submitted
- 10 Apr 2012
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Utility of Indomethacin as Support Treatment in Women With Preterm Labor With Intact Membranes and High Risk of Intraamniotic Inflammation
- ClinicalTrials.gov ID
- NCT01577121
- Acronym / sponsor ID
- INDOGEST / INDOGEST
- Conditions
- Preterm Labor With Intact Membranes
- Keywords
- Preterm labor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sara VareaUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Apr 2012 (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.
To demonstrate if indomethacin associated to conventional treatment for preterm labor is useful to delay delivery and to improve neonatal morbimortality in women with preterm labor with high risk of intraamniotic inflammation
Detailed description
Randomised patients would be assigned to receive indomethacin either placebo oral use(50 mg every 6 hours during 5 days) to evaluate the efficacy of indomethacin as complementary treatment to increase the gestational age at delivery in women admitted with preterm labor and intact membranes with high risk of intraamniotic inflammation, defined as a gestational age at admission less than 28.0 weeks or those women from 28-32.0 weeks with a sonographic cervical length less than 15 mm
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| indomethacin | Experimental | Drug: indomethacin50 mg/ 6 hours of indomethacin oral use |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- pregnant women with preterm labor admitted to hospital and treated with tocolysis
- pregnant women less than 28.0 and those women from 28.0 to 32.0 with a sonographic cervical length < 15 mm
- single pregnancy
- normal amniotic fluid
- normal arterial ductus
Key exclusion criteria (8 listed)
- Age below 18 years
- previous use of indomethacin in the index pregnancy
- chorioamnionitis, preterm prelabour rupture of membranes or those fetal or maternal pathologies which could be responsible of an iatrogenic preterm delivery.
- oligohydramnios
- allergy to NSAID
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 |
|---|---|---|
| indomethacin50 mg / 6 hours during 5 days | Drug | indomethacin |
| placebo50 mg / 6 hours during 5 days | Drug | placebo |
Primary outcome
Gestational age at delivery
Time frame: before than 42 weeks of gestation
number of weeks and days at delivery
7 secondary outcomes
proportion of patients with spontaneous preterm delivery before 34 weeks of gestation
Time frame: at the end of study (maximum 1 year)
Incidence of adverse events
Time frame: 1 year (end of study)
Latency from admission to delivery
Time frame: between initial admission and delivery (before 42 weeks of gestation)
IL-6 levels in amniotic fluid and umbilical cord blood
Time frame: delivery (maximum 42 weeks of gestational age)
Number of emergency visits
Time frame: between initial admission and delivery (before 42 weeks of gestation)
Neonatal morbidity
Time frame: at the end of the study (1 year)
Neonatal death
Time frame: at the end of the study (1 year)
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 21 Oct 2014.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 indomethacin in people with Preterm Labor With Intact Membranes, run by Sara Varea at 1 site in Spain.
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 8 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 21 Oct 2014. 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 Spain. 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?
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?
Gestational age at delivery (time frame: before than 42 weeks of gestation). 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 NCT01577121, 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 21 Oct 2014.