Preterm BirthNCT03501030
Activity Restriction for Women With Arrested Preterm Labor
A study testing Activity restriction in people with Preterm Birth, run by Federico II University at 1 site in Italy.
Trial summary
to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Activity restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 25 Nov 2019to 1 Oct 2021
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- singleton gestations;
- arrested PTL;
- TVU CL < 25 mm;
- 18 years to 50 years.
Who cannot join
- multiple gestations;
- symptoms of PTL (not arrested PTL);
- TVU CL ≥ 25mm;
- premature rupture of amnion and chorion membranes (PROM) at the time of randomization;
- cerclage in situ at the time of randomization;
- pessary in situ at the time of randomization;
Show all 9Show fewer
- vaginal bleeding at the time of randomization;
- women who are unconscious, severly ill, mentally handicapped;
- women under the age of 18 years or over the age of 50 years.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Giuseppe De Placido
Naples, 80129
Giuseppe De Placido, 7462979, gabriele.saccone.1990@gmail.com
About this study
Official title: Activity Restriction for Women With Arrested Preterm Labor: a Randomized Controlled Trial
to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.
Read the detailed description
Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors.
Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs that can slow or stop labor contractions in the attempt to delay births preceded by PTL. Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In most of these women, PTL stops, but as their risk of PTB remains high, some have advocated use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance tocolytic agent has been shown to be beneficial in preventing PTB.
Some authors have also advocated the use of activity restriction in women with arrested PTL to reduce the risk of PTB. Activity restriction is defined as the following forms of activity restriction: pelvic rest and prohibition of sexual activity, reduction of work and/or non work activity. So far, the benefit of activity restriction in women with arrested PTL is still subject of debate and no Randomized Controlled Trial (RCT) has been undertaken.
Thus, the aim of this trial is to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.
- Conditions
- Preterm Birth
- Being tested
- Activity restriction
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity restrictionBehavioural
Women in the intervention group will be recommended activity restriction. Activity restriction is defined as the following forms of activity restriction: pelvic rest and prohibition of sexual activity, reduction of work and/or non work activity. Bed rest will not recommended.
| Study group | Role | What they receive |
|---|---|---|
| Activity restriction | Experimental | Women in the intervention group will be recommended activity restriction. Activity restriction is defined as the following forms of activity restriction: pelvic rest and prohibition of sexual activity, reduction of work and/or non work activity. Bed rest will not recommended. Receives: Behavioral: Activity restriction |
| No activity restriction | No intervention | Women in the control group will not receive any reccomandation regarding activity restriction. Bed rest and abstain from sexual intercourse will also not recommended. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm birth
Preterm delivery at less than 37 weeks of gestation
Measured: 37 weeks of gestation
Secondary outcomes (6)
Mean gestational age at delivery in weeks
Mean gestational age at delivery in weeks
Measured: At the time of delivery
Mean latency
from randomization to delivery
Measured: from randomization to delivery
admission to nicu
number of babies admitted to neonatal intensive care unit
Measured: at the time of delivery until 28 days of life
neonatal death
death of a live-born baby
Measured: at the time of delivery until 28 days of life
a composite of adverse perinatal outcome
defined as at least one of the following:
- necrotizing enterocolitis (NEC);
- intraventricular hemorrhage (IVH) grade 3 or higher;
- respiratory distress syndrome (RDS);
- bronchopulmonry dysplasia (BPD);
- retinopathy of prematurity (ROP) requiring therapy;
- blood-culture proven sepsis;
- admission to neonatal intensive care unit (NICU);
- neonatal death;
Measured: at the time of delivery until 28 days of life
chorioamnionitis
diagnosis of choriamnionitis at histological examination of the placenta.
Measured: at the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start25 Nov 2019
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Oct 2021 (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 BirthStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, parallel group non-blinded, prospective, interventional non-pharmacologic, no profit, randomized and controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Saccone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501030
- Sponsor's protocol ID
- 29/18
- Status last verified
- Aug 2021
- First submitted
- 10 Apr 2018
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saccone G, Della Corte L, Cuomo L, Reppuccia S, Murolo C, Napoli FD, Locci M, Bifulco G. Activity restriction for women with arrested preterm labor: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Aug;5(8):100954. doi: 10.1016/j.ajogmf.2023.100954. Epub 2023 Apr 18.
PubMed 37080296
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activity Restriction for Women With Arrested Preterm Labor: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03501030
- Acronym / sponsor ID
- 29/18
- Conditions
- Preterm Birth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 18 Apr 2018 (actual)
- 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 test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.
Detailed description
Preterm birth (PTB) is a major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors.
Preterm labor (PTL) is the final pathway for about 50% of all PTB. Tocolytic agents are drugs that can slow or stop labor contractions in the attempt to delay births preceded by PTL. Primary tocolysis is defined as tocolysis given on initial presentation of women with PTL. In most of these women, PTL stops, but as their risk of PTB remains high, some have advocated use of maintenance tocolysis, i.e. tocolysis after arrested PTL. So far, no maintenance tocolytic agent has been shown to be beneficial in preventing PTB.
Some authors have also advocated the use of activity restriction in women with arrested PTL to reduce the risk of PTB. Activity restriction is defined as the following forms of activity restriction: pelvic rest and prohibition of sexual activity, reduction of work and/or non work activity. So far, the benefit of activity restriction in women with arrested PTL is still subject of debate and no Randomized Controlled Trial (RCT) has been undertaken.
Thus, the aim of this trial is to test the hypothesis that activity restriction in women with singleton gestations and with arrested PTL would reduce the rate of PTB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, parallel group non-blinded, prospective, interventional non-pharmacologic, no profit, randomized and controlled trial
| Arm | Type | Receives |
|---|---|---|
| Activity restriction | Experimental | Behavioral: Activity restrictionWomen in the intervention group will be recommended activity restriction. Activity restriction is defined as the following forms of activity restriction: pelvic rest and prohibition of sexual activity, reduction of work and/or non work activity. Bed rest will not recommended. |
| No activity restriction | No intervention | –Women in the control group will not receive any reccomandation regarding activity restriction. Bed rest and abstain from sexual intercourse will also not recommended. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- singleton gestations;
- arrested PTL;
- TVU CL < 25 mm;
- 18 years to 50 years.
Key exclusion criteria (9 listed)
- multiple gestations;
- symptoms of PTL (not arrested PTL);
- TVU CL ≥ 25mm;
- premature rupture of amnion and chorion membranes (PROM) at the time of randomization;
- cerclage in situ at the time of randomization;
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 |
|---|---|---|
| Activity restrictionWomen in the intervention group will be recommended activity restriction. Activity restriction is defined as the following forms of activity restriction: pelvic rest and prohibition of sexual activity, reduction of work and/or non work activity. Bed rest will not recommended. | Behavioural | Activity restriction |
Primary outcome
Preterm birth
Time frame: 37 weeks of gestation
Preterm delivery at less than 37 weeks of gestation
6 secondary outcomes
Mean gestational age at delivery in weeks
Time frame: At the time of delivery
Mean latency
Time frame: from randomization to delivery
admission to nicu
Time frame: at the time of delivery until 28 days of life
neonatal death
Time frame: at the time of delivery until 28 days of life
a composite of adverse perinatal outcome
Time frame: at the time of delivery until 28 days of life
chorioamnionitis
Time frame: at the time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 37080296Saccone G, Della Corte L, Cuomo L, Reppuccia S, Murolo C, Napoli FD, Locci M, Bifulco G. Activity restriction for women with arrested preterm labor: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Aug;5(8):100954. doi: 10.1016/j.ajogmf.2023.100954. Epub 2023 Apr 18.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity restriction in people with Preterm Birth, run by Federico II University at 1 site in Italy.
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 4 inclusion and 9 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 24 Aug 2021. 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 Italy. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm birth (time frame: 37 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 NCT03501030, 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 24 Aug 2021.