Pregnancy, ProlongedMILONCT04307199
Membrane Sweeping to Prevent Post-term Pregnancy: The MILO Study
A study testing Amniotic membrane sweep in people with Pregnancy, Prolonged and Induced; Birth, run by National University of Ireland, Galway, Ireland.
Trial summary
Multicentre, pragmatic, parallel group, pilot randomised controlled trial with an embedded factorial design. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Prolonged, Induced; Birth, Pregnancy Related
- What is being tested?
- Amniotic membrane sweep
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2020to 30 Dec 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women carrying a live singleton fetus ≥ 38 weeks completed gestation.
- (Gestational age will be calculated from the first day of the last menstrual period and an
- ultrasound examination carried out in the 2nd trimester)
- Longitudinal lie
- Cephalic presentation
- Intact amniotic
- ≥ 18 years of age on enrollment
Who cannot join
- Not able to communicate in english
- contraindications to a vaginal examination
- contraindications to a vaginal birth
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility Study Protocol of a Pragmatic, Randomised Controlled Pilot Trial: Membrane Sweeping to Prevent Post-term Pregnancy: The MILO Study
Multicentre, pragmatic, parallel group, pilot randomised controlled trial with an embedded factorial design.
Read the detailed description
The primary aim of the MILO study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. We will also assess the acceptability and feasibility of the proposed trial interventions to clinicians and women (through focus group interviews).
Methods/Design
Multicentre, pragmatic, parallel group, pilot randomised controlled trial with an embedded factorial design. Pregnant women with a live, singleton fetus ≥ 38 weeks gestation, cephalic presentation, longitudinal lie, intact membranes, English speaking and ≥18 years of age will be randomised in a 2:1 ratio to:
- Membrane sweep versus no membrane sweep
Women allocated randomly to a sweep will then be randomised further (factorial component) to:
- early (from 39 weeks) versus late (from 40 weeks) sweep commencement; and
- a single verses weekly sweep
The proposed feasibility study consists of four work packages i.e., (1) a multicentre, pilot randomised trial, 2) a health economic analysis and 3) a qualitative study (4) a study within the host trial (a SWAT).
- Conditions
- Pregnancy, Prolonged, Induced; Birth, Pregnancy Related
- Being tested
- Amniotic membrane sweep
- Keywords
- membrane sweep, feasibility study, randomised trial, pilot study, SWAT, pregnancy, induction of labour, post dates, prolonged pregnancy
- Medical subject headings
- Pregnancy, Prolonged
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic membrane sweepProcedure or surgery
Amniotic membrane sweeping is defined as the manual detachment of the inferior pole of the amniotic membranes from the lower uterine segment. This is performed with consent by a clinician digitally through a circular motion during a vaginal examination. If the cervical os is closed massage of the cervix will be accepted.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Membrane sweep @ 39 weeks' gestation only Receives: Procedure: Amniotic membrane sweep |
| Group B | Experimental | Membrane sweep @ 40 weeks' gestation only Receives: Procedure: Amniotic membrane sweep |
| Group C | Experimental | Membrane sweep @ 39, 40 and 41 weeks' gestation or until onset of labour Receives: Procedure: Amniotic membrane sweep |
| Group D | Experimental | Membrane sweep @ 40 and 41 weeks' gestation or until onset of labour Receives: Procedure: Amniotic membrane sweep |
| Control Group | No intervention | Women in the control arm will not receive a membrane sweep and will receive usual care (as defined by local hospital protocols and vaginal examination to determine Bishop score only). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Evaluation of the number and percentage of eligible women who are recruited and randomised to the study. Assessed by study-specific checklists.
Measured: Duration of the recruitment process (approximately 8 months )
Retention
Evaluation of the number and percentage of eligible women who are randomised, take part in and adhere to the study protocols. Data will be extracted from routinely collected data.
Measured: At month 15 approximately
Adherence with the trial interventions.
Evaluation of adherence with the trial interventions, and reasons for non-compliance assessed by study-specific checklists. Data will be extracted from routinely collected data and focus group interviews with clinicians and participants at six weeks post intervention.
Measured: At month 15 approximately
Evaluation of the randomisation process.
Evaluation of effective allocation of participants to the intervention/control group assessed by study-specific checklists and evaluation of the randomisation protocol throughout the randomisation period.
Measured: At month 15 approximately
Evaluation of attrition rates
Evaluation of attrition rates assessed by study-specific checklists. Data will be extracted from routinely collected data.
Measured: At month 15 approximately
Evaluation of the types of attrition
Evaluation of the types of attrition assessed by case report forms. Data will be extracted from routinely collected data.
Measured: At month 21 approximately
Evaluation of the data collection process through study specific checklists
Evaluated, statistically and narratively, by assessing the completeness of outcome measurements at baseline and postnatal (6 weeks) through study specific checklists. Researchers will manually examine the data collected. They will assess the proportion of complete data collection forms, the quality of data collected and the applicability of this data in facilitating pilot trial outcomes.
Measured: At month 21 approximately
Estimate the main effect of individual intervention components and their interactions
Estimates (with measures of uncertainty) of the main effect of individual intervention components and any interaction effect between the main effects of the embedded factorial design will be assessed and reported using regression analysis.
Measured: At month 21 approximately
Evaluation of the data analysis process
As this is a feasibility study formal hypothesis testing will not be undertaken. Researchers will manually examine the data collected. Evaluation of the data analysis process will be undertaken through the assessment of gaps and limitations to the analysis process measured by study-specific checklist. Findings will be reported through descriptive statistics and graphical summaries.
Measured: At month 21 approximately
Evaluation of the EQ5D
Assessment of the mechanism of, timing of and delivery of the EQ5D through study specific checklists.
Measured: At month 21 approximately
Feasibility of cost analyses process through analysis of study specific documentation.
Assessment of data collection tools to undertake cost effectiveness analysis through study specific documentation. Researchers will manually examine data to assess the mechanism of, timing of and delivery of the cost analysis tools.
Measured: At month 21 approximately
Feasibility of the cost effectiveness analyses
Assessment of the mechanism and utilisation of the incremental cost-effectiveness ratio (ICER), through study specific checklists.
Measured: At month 21 approximately
Secondary outcomes (24)
Number of participants achieving a spontaneous onset of labour
Labour which begins spontaneously.
Measured: From time of randomisation to commencement of spontaneous onset of labour or formal induction of labour or caesarean section (up to 5 weeks)
Number of participants who underwent an induction of labour
Formal induction of labour using pharmacological or surgical methods.
Measured: From time of randomisation to commencement of formal induction of labour (up to 5 weeks).
Number of participants achieving a spontaneous vaginal birth
Spontaneous vaginal birth
Measured: From time of randomisation to birth of baby (up to 5 weeks)
Instrumental birth
Vaginal birth which is assisted with the use of instruments.
Measured: From time of randomisation to birth of baby (up to 5 weeks)
Caesarean Section
Birth which is achieved through the surgical procedure caesarean section.
Measured: From time of randomisation to birth of baby (up to 5 weeks)
Post-Partum Haemorrhage ≥ 500mls
Blood loss ≥ 500mls within the first 24 hours of the birth of a baby
Measured: From time of birth to 24 hours after the birth of baby.
Antepartum haemorrhage requiring hospital admission
Bleeding from the genital tract, from 24+0 weeks of pregnancy and before the birth of the baby.
Measured: From 24+0 weeks of pregnancy to birth of baby (up to 18 weeks)
Uterine hyperstimulation with/without fetal heart rate (FHR) changes
Uterine hyperstimulation defined as uterine tachysystole (more than five contractions per ten minutes for at least twenty minutes) and uterine hypersystole/hypertonicity (a contraction lasting at least two minutes). These may or not be associated with changes in the fetal heart rate pattern (persistent decelerations, tachycardia or decreased short term variability.
Measured: From time of randomisation to birth of baby (up to 5 weeks)
Serious maternal death or morbidity
Serious maternal death or morbidity (e.g. uterine rupture, admission to intensive care unit, septicaemia)
Measured: From time of randomisation to six weeks postnatal (up to 11 weeks).
Epidural analgesia
Introduction of a local anaesthetic into the epidural space of the vertebral canal.
Measured: From time of randomisation to birth of baby (up to 5 weeks)
Augmentation of labour
The stimulation of uterine contractions using pharmacologic methods or artificial rupture of membranes to increase their frequency and/or strength following the onset of spontaneous labor or contractions following spontaneous rupture of membranes (ACOG 2014)
Measured: From commencement of established labour to birth of baby (up to 2 days)
Pyrexia in labour
Pyrexia that developed anytime after onset of labour.
Measured: From commencement of established labour to birth of baby (up to 2 days)
Uterine rupture
All clinically significant ruptures of unscarred or scarred uteri. Trivial scar dehiscence noted incidentally at the time of surgery will be excluded
Measured: From time of randomisation to birth of baby (up to 5 weeks)
EQ5D-5L
EuroQol EQ5D-5L survey instrument.
Measured: From time of randomisation to six weeks postnatal (up to 11 weeks)
Serious neonatal morbidity
e.g. seizures, birth asphyxia defined by trialists, neonatal encephalopathy, disability in childhood, Proven and suspected neonatal sepsis
Measured: From time of birth of baby to six weeks postnatal.
Apgar score < 7 at five minutes.
The Apgar score provides an accepted and convenient method for reporting the status of the newborn infant immediately after birth and the response to resuscitation if needed (ACOG 2015).
Measured: From birth of baby to five minutes of life.
Cord PH < 7.20
Umbilical cord blood gas test.
Measured: From birth of infant to collection of cord bloods after delivery of the placenta (an average of 15 minutes)
Neonatal encephalopathy
Severity of hypoxic ischaemic encephalopathy assessed using Sarnat staging; i)Stage 1 (mild): hyper-alertness, hyper-reflexia, dilated pupils, tachycardia, absence of seizures; ii)Stage 2 (moderate): lethargy, hyper-reflexia, miosis, bradycardia, seizures, hypotonia with weak suck and Moro reflexes; iii)Stage 3 (severe): stupor, flaccidity, small to mid-position pupils which react poorly to light, decreased stretch reflexes, hypothermia and absent Moro reflex.
Measured: From time of birth to six weeks postnatal.
Perinatal death
The perinatal period is defined as "commences at 22 completed weeks (154 days) of gestation and ends seven completed days after birth of baby."
Measured: From time of randomisation to seven completed days after birth of baby (up to 6 weeks)
Admission to neonatal intensive care unit or equivalent
Admission of infant to neonatal intensive care unit or equivalent
Measured: From time of birth to six weeks postnatal.
Length of time from membrane sweep to birth of baby.
Length of time from membrane sweep to birth of baby .
Measured: From time of membrane sweep to birth of baby (up to 4 weeks)
Length of time from formal induction of labour to birth of baby.
Length of time from formal induction of labour to birth of baby.
Measured: From time of formal induction of labour to birth of baby (up to 2 weeks)
Overall length of maternal hospital stay
Overall length of maternal hospital stay
Measured: From time of randomisation to six weeks postnatal (up to 11 weeks).
Length of infant stay in neonatal intensive care unit or equivalent
Length of infant stay in neonatal intensive care unit or equivalent
Measured: From time of birth to six weeks postnatal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start30 Jul 2020 (estimated)
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Dec 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 Pregnancy, ProlongedStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Women will initially be randomised in a 2:1 ratio to: • Membrane sweep (2) versus no membrane sweep (1). Those allocated to the intervention group will then be further randomised in a factorial fashion to A, B, C or D: A. Membrane sweep @ 39 weeks' gestation only B. Membrane sweep @ 40 weeks' gestation only C. Membrane sweep @ 39, 40 and 41 weeks' gestation or until onset of labour D. Membrane sweep @ 40 and 41 weeks' gestation or until onset of labour
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Principal investigator, Prof. Declan Devane, National University of Ireland, Galway, Ireland
- Investigators
- Declan Devane, PhD, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307199
- Sponsor's protocol ID
- NUIreland - MILO
- Acronym
- MILO
- Status last verified
- May 2020
- First submitted
- 17 Jan 2020
- Last updated
- 14 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finucane EM, Biesty L, Murphy D, Cotter A, Molloy E, O'Donnell M, Treweek S, Gillespie P, Campbell M, Morrison JJ, Alvarez-Iglesias A, Gyte G, Devane D. Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy-the MILO Study. Trials. 2021 Feb 2;22(1):113. doi: 10.1186/s13063-021-05043-9.
PubMed 33531062
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Protocol of a Pragmatic, Randomised Controlled Pilot Trial: Membrane Sweeping to Prevent Post-term Pregnancy: The MILO Study
- ClinicalTrials.gov ID
- NCT04307199
- Acronym / sponsor ID
- MILO / NUIreland - MILO
- Conditions
- Pregnancy, Prolonged, Induced; Birth, Pregnancy Related
- Keywords
- membrane sweep, feasibility study, randomised trial, pilot study, SWAT, pregnancy, induction of labour, post dates
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- 30 Jul 2020 (estimated)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 13 Mar 2020 (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.
Multicentre, pragmatic, parallel group, pilot randomised controlled trial with an embedded factorial design.
Detailed description
The primary aim of the MILO study is to inform the optimal design of a future definitive randomised trial to evaluate the effectiveness (including optimal timing and frequency) of membrane sweeping to prevent post-term pregnancy. We will also assess the acceptability and feasibility of the proposed trial interventions to clinicians and women (through focus group interviews).
Methods/Design
Multicentre, pragmatic, parallel group, pilot randomised controlled trial with an embedded factorial design. Pregnant women with a live, singleton fetus ≥ 38 weeks gestation, cephalic presentation, longitudinal lie, intact membranes, English speaking and ≥18 years of age will be randomised in a 2:1 ratio to:
- Membrane sweep versus no membrane sweep
Women allocated randomly to a sweep will then be randomised further (factorial component) to:
- early (from 39 weeks) versus late (from 40 weeks) sweep commencement; and
- a single verses weekly sweep
The proposed feasibility study consists of four work packages i.e., (1) a multicentre, pilot randomised trial, 2) a health economic analysis and 3) a qualitative study (4) a study within the host trial (a SWAT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- Women will initially be randomised in a 2:1 ratio to: • Membrane sweep (2) versus no membrane sweep (1). Those allocated to the intervention group will then be further randomised in a factorial fashion to A, B, C or D: A. Membrane sweep @ 39 weeks' gestation only B. Membrane sweep @ 40 weeks' gestation only C. Membrane sweep @ 39, 40 and 41 weeks' gestation or until onset of labour D. Membrane sweep @ 40 and 41 weeks' gestation or until onset of labour
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Amniotic membrane sweepMembrane sweep @ 39 weeks' gestation only |
| Group B | Experimental | Procedure: Amniotic membrane sweepMembrane sweep @ 40 weeks' gestation only |
| Group C | Experimental | Procedure: Amniotic membrane sweepMembrane sweep @ 39, 40 and 41 weeks' gestation or until onset of labour |
| Group D | Experimental | Procedure: Amniotic membrane sweepMembrane sweep @ 40 and 41 weeks' gestation or until onset of labour |
| Control Group | No intervention | –Women in the control arm will not receive a membrane sweep and will receive usual care (as defined by local hospital protocols and vaginal examination to determine Bishop score only). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pregnant women carrying a live singleton fetus ≥ 38 weeks completed gestation.
- (Gestational age will be calculated from the first day of the last menstrual period and an
- ultrasound examination carried out in the 2nd trimester)
- Longitudinal lie
- Cephalic presentation
Key exclusion criteria (3 listed)
- Not able to communicate in english
- contraindications to a vaginal examination
- contraindications to a vaginal birth
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 |
|---|---|---|
| Amniotic membrane sweepAmniotic membrane sweeping is defined as the manual detachment of the inferior pole of the amniotic membranes from the lower uterine segment. This is performed with consent by a clinician digitally through a circular motion during a vaginal examination. If the cervical os is closed massage of the cervix will be accepted. | Procedure or surgery | Group A, Group B, Group C, Group D |
Primary outcome
Recruitment
Time frame: Duration of the recruitment process (approximately 8 months )
Evaluation of the number and percentage of eligible women who are recruited and randomised to the study. Assessed by study-specific checklists.
Retention
Time frame: At month 15 approximately
Evaluation of the number and percentage of eligible women who are randomised, take part in and adhere to the study protocols. Data will be extracted from routinely collected data.
Adherence with the trial interventions.
Time frame: At month 15 approximately
Evaluation of adherence with the trial interventions, and reasons for non-compliance assessed by study-specific checklists. Data will be extracted from routinely collected data and focus group interviews with clinicians and participants at six weeks post intervention.
Evaluation of the randomisation process.
Time frame: At month 15 approximately
Evaluation of effective allocation of participants to the intervention/control group assessed by study-specific checklists and evaluation of the randomisation protocol throughout the randomisation period.
Evaluation of attrition rates
Time frame: At month 15 approximately
Evaluation of attrition rates assessed by study-specific checklists. Data will be extracted from routinely collected data.
Evaluation of the types of attrition
Time frame: At month 21 approximately
Evaluation of the types of attrition assessed by case report forms. Data will be extracted from routinely collected data.
Evaluation of the data collection process through study specific checklists
Time frame: At month 21 approximately
Evaluated, statistically and narratively, by assessing the completeness of outcome measurements at baseline and postnatal (6 weeks) through study specific checklists. Researchers will manually examine the data collected. They will assess the proportion of complete data collection forms, the quality of data collected and the applicability of this data in facilitating pilot trial outcomes.
Estimate the main effect of individual intervention components and their interactions
Time frame: At month 21 approximately
Estimates (with measures of uncertainty) of the main effect of individual intervention components and any interaction effect between the main effects of the embedded factorial design will be assessed and reported using regression analysis.
Evaluation of the data analysis process
Time frame: At month 21 approximately
As this is a feasibility study formal hypothesis testing will not be undertaken. Researchers will manually examine the data collected. Evaluation of the data analysis process will be undertaken through the assessment of gaps and limitations to the analysis process measured by study-specific checklist. Findings will be reported through descriptive statistics and graphical summaries.
Evaluation of the EQ5D
Time frame: At month 21 approximately
Assessment of the mechanism of, timing of and delivery of the EQ5D through study specific checklists.
Feasibility of cost analyses process through analysis of study specific documentation.
Time frame: At month 21 approximately
Assessment of data collection tools to undertake cost effectiveness analysis through study specific documentation. Researchers will manually examine data to assess the mechanism of, timing of and delivery of the cost analysis tools.
Feasibility of the cost effectiveness analyses
Time frame: At month 21 approximately
Assessment of the mechanism and utilisation of the incremental cost-effectiveness ratio (ICER), through study specific checklists.
24 secondary outcomes
Number of participants achieving a spontaneous onset of labour
Time frame: From time of randomisation to commencement of spontaneous onset of labour or formal induction of labour or caesarean section (up to 5 weeks)
Number of participants who underwent an induction of labour
Time frame: From time of randomisation to commencement of formal induction of labour (up to 5 weeks).
Number of participants achieving a spontaneous vaginal birth
Time frame: From time of randomisation to birth of baby (up to 5 weeks)
Instrumental birth
Time frame: From time of randomisation to birth of baby (up to 5 weeks)
Caesarean Section
Time frame: From time of randomisation to birth of baby (up to 5 weeks)
Post-Partum Haemorrhage ≥ 500mls
Time frame: From time of birth to 24 hours after the birth of baby.
Antepartum haemorrhage requiring hospital admission
Time frame: From 24+0 weeks of pregnancy to birth of baby (up to 18 weeks)
Uterine hyperstimulation with/without fetal heart rate (FHR) changes
Time frame: From time of randomisation to birth of baby (up to 5 weeks)
Serious maternal death or morbidity
Time frame: From time of randomisation to six weeks postnatal (up to 11 weeks).
Epidural analgesia
Time frame: From time of randomisation to birth of baby (up to 5 weeks)
Augmentation of labour
Time frame: From commencement of established labour to birth of baby (up to 2 days)
Pyrexia in labour
Time frame: From commencement of established labour to birth of baby (up to 2 days)
Uterine rupture
Time frame: From time of randomisation to birth of baby (up to 5 weeks)
EQ5D-5L
Time frame: From time of randomisation to six weeks postnatal (up to 11 weeks)
Serious neonatal morbidity
Time frame: From time of birth of baby to six weeks postnatal.
Apgar score < 7 at five minutes.
Time frame: From birth of baby to five minutes of life.
Cord PH < 7.20
Time frame: From birth of infant to collection of cord bloods after delivery of the placenta (an average of 15 minutes)
Neonatal encephalopathy
Time frame: From time of birth to six weeks postnatal.
Perinatal death
Time frame: From time of randomisation to seven completed days after birth of baby (up to 6 weeks)
Admission to neonatal intensive care unit or equivalent
Time frame: From time of birth to six weeks postnatal.
Length of time from membrane sweep to birth of baby.
Time frame: From time of membrane sweep to birth of baby (up to 4 weeks)
Length of time from formal induction of labour to birth of baby.
Time frame: From time of formal induction of labour to birth of baby (up to 2 weeks)
Overall length of maternal hospital stay
Time frame: From time of randomisation to six weeks postnatal (up to 11 weeks).
Length of infant stay in neonatal intensive care unit or equivalent
Time frame: From time of birth to six weeks postnatal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Derived from this study: PubMed 33531062Finucane EM, Biesty L, Murphy D, Cotter A, Molloy E, O'Donnell M, Treweek S, Gillespie P, Campbell M, Morrison JJ, Alvarez-Iglesias A, Gyte G, Devane D. Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy-the MILO Study. Trials. 2021 Feb 2;22(1):113. doi: 10.1186/s13063-021-05043-9.
- 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.
Declan Devane, PhD principal investigator
National University of Ireland, Galway, Ireland
Questions about this trial
What is this clinical trial studying?
A study testing Amniotic membrane sweep in people with Pregnancy, Prolonged and Induced; Birth, run by National University of Ireland, Galway, Ireland.
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 7 inclusion and 3 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 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Elaine M Finucane, BSc (+353 91 495938, Elainemay.finucane@nuigalway.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Duration of the recruitment process (approximately 8 months )). The study lists 12 primary outcomes in all. 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 NCT04307199, 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 14 May 2020.