Preterm PregnancyPITANCT03504670
Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial
A study testing Early Amniotomy and Late Amniotomy in people with Preterm Pregnancy and Labor Induction, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Artificial rupture of membranes (amniotomy) is a commonly used technique to safely induce and augment labor. It has been shown to reduce the duration of spontaneous and induced labor in term patients (≥37 weeks' gestation). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Pregnancy, Labor Induction
- What is being tested?
- Early Amniotomy and Late Amniotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2018to 13 Jan 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton gestation
- Gestational age at randomization between 23.0 and 35.6 weeks
- Induction of labor planned for maternal or fetal indications
- Reassuring fetal status
- Vertex presentation
Who cannot join
- Plan for cesarean delivery or contraindication to labor
- Cervix ≥4cm dilated at start of induction
- Signs of spontaneous labor (active contractions with cervical change)
- Ruptured membranes
- Chorioamnionitis
- Intrauterine fetal demise
Show all 10Show fewer
- Known major fetal anomaly
- Participation in any other clinical trial involving the course of labor
- Maternal hepatitis B, C, or HIV infection (or unknown status)
- Deferring intrapartum fetal monitoring and/or cesarean section for any reason (for example, after periviability counseling)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmigham, Women and Infants' Center
Birmingham, Alabama, 35233
About this study
Artificial rupture of membranes (amniotomy) is a commonly used technique to safely induce and augment labor. It has been shown to reduce the duration of spontaneous and induced labor in term patients (≥37 weeks' gestation). The utility of amniotomy in preterm patients (<37 weeks' gestation) undergoing medically-indicated induction of labor is unknown. However, it remains a commonly used strategy. We will conduct a trial comparing early amniotomy versus late amniotomy during medically-indicated induction of labor between 23.0 and 35.6 weeks gestation. Women will be randomized to early or late amniotomy after the obstetrician has decided to induce labor for a medical indication. We hypothesize that more women in the early amniotomy group will require cesarean delivery, and the duration of labor will increase in the early amniotomy group.
Read the detailed description
The rate of preterm birth in the United States is nearly 10%. Up to one-third of these births are the result of a medically-indicated delivery. While induction of labor in women at term gestation has been extensively studied, the same is not true for preterm gestations. Consequently, the same methods of labor induction are used in term and preterm gestations, although preterm gestations may have different responses to induction agents compared to term gestations.
At our institution, a standard induction of labor - for term or preterm women - is performed using a cervical Foley catheter or misoprostol for cervical ripening with the addition of intravenous oxytocin for labor augmentation. As membranes do not typically spontaneously rupture during the induction process, amniotomy is commonly utilized by providers to help augment labor. Amniotomy releases prostaglandin-rich amniotic fluid. These prostaglandins are important mediators of uterine contractility and ultimately active labor. It has been shown to reduce the duration of spontaneous and induced labor in term patients.
The timing of amniotomy is left up to the discretion of the treating providers, as there are no randomized controlled trials to support early versus late amniotomy at preterm gestations. However, a retrospective cohort of nulliparous and multiparous women at our institution undergoing induction at 23-34 weeks, and evaluating early amniotomy at <4cm cervical dilation versus late amniotomy at ≥4cm dilation, showed an increased risk of cesarean delivery and increased time from start of induction to delivery for early amniotomy, although only the cesarean delivery outcome was significant after adjusting for confounders.
We will conduct an intention-to-treat randomized controlled trial comparing early amniotomy versus late amniotomy during medically-indicated induction of labor between 23.0 and 35.6 weeks gestation. Women will be randomized to early or late amniotomy after the attending obstetrician has decided to induce labor for a medical indication. Early amniotomy will be performed prior to 4cm cervical dilation being reached. Late amniotomy will be performed at greater than or equal to 4cm cervical dilation.
The purpose of this study is to determine whether timing of amniotomy during medically-indicated preterm induction of labor affects labor outcomes. We will specifically be looking at risk of cesarean delivery, duration of labor, maternal morbidity, and neonatal morbidity. We hypothesize that more women in the early amniotomy group will require cesarean delivery and that the duration of labor will increase in the early amniotomy group.
- Conditions
- Preterm Pregnancy, Labor Induction
- Being tested
- Early Amniotomy, Late Amniotomy
- Keywords
- Labor induction, Cesarean delivery, Preterm labor induction, Duration of labor induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early AmniotomyProcedure or surgery
This intervention involves using an amniotomy hook to rupture the membranes during a sterile vaginal exam. This intervention will be performed prior to the cervix being dilated 4cm.
Late AmniotomyProcedure or surgery
This intervention involves using an amniotomy hook to rupture the membranes during a sterile vaginal exam. This intervention will be performed once the cervix is at least 4cm dilated.
| Study group | Role | What they receive |
|---|---|---|
| Early amniotomy | Experimental | Women randomized to early amniotomy will have their membranes ruptured in usual fashion using an amniotomy hook when the cervix is less than 4cm dilated. This will occur after cervical ripening has taken place, with 1) a cervical Foley balloon catheter with or without oxytocin and/or 2) misoprostol. Prior to amniotomy, the obstetric provider will assess whether or not the fetal head is engaged. If the fetal head is not engaged (applied to the cervix), amniotomy will be deferred. The patient will be examined every 2 hours until amniotomy can be safely performed (in keeping with our institutional standard of care to examine women every 2-4 hours in labor). Receives: Procedure: Early Amniotomy |
| Late amniotomy | Experimental | Women randomized to late amniotomy will have their membranes ruptured once the cervix reaches at least 4cm dilation. This will occur after cervical ripening has taken place, with 1) a cervical Foley balloon catheter with or without oxytocin and/or 2) misoprostol. If the cervix fails to reach 4cm dilation 12 hours following cervical ripening, amniotomy will be performed. Receives: Procedure: Late Amniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean delivery
Proportion of women requiring cesarean delivery
Measured: Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.
Secondary outcomes (4)
Interval from induction onset to delivery
Time (hours) from the start of induction (initiation of first cervical ripening agent) to delivery (vaginal or cesarean)
Measured: Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.
Interval from induction onset to vaginal delivery
Time (hours) from the start of induction (initiation of first cervical ripening agent) to vaginal delivery only
Measured: Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.
Composite maternal morbidity
Composed of seven outcomes:
- chorioamnionitis (defined as maternal fever >100.3 plus maternal tachycardia, fetal tachycardia, purulent amniotic fluid, or fundal tenderness prior to delivery)
- endometritis (defined as maternal fever >100.3 at least 12 hours after delivery with fundal tenderness or purulent discharge)
- surgical site infection (infection within 30 days at the surgical site including superficial, deep, organ/space infections)
- pneumonia (radiologic diagnosis of pneumonia accompanied by clinical signs/symptoms)
- urinary tract infection (>100,000 colonies of a single species in urine culture accompanied by clinical signs/symptoms)
- postpartum hemorrhage (estimated blood loss >1000 mL)
- umbilical cord prolapse
Measured: Measured from start of induction of labor up to 42 days following delivery
Composite neonatal morbidity
Composed of five outcomes:
- perinatal death (death of a fetus during labor or within 28 days of life)
- neonatal sepsis (critically ill infant in whom systemic infection is suspected with a positive blood, cerebrospinal fluid (CSF), or catheterized/suprapubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an unequivocal X-ray confirming infection)
- intraventricular hemorrhage (confirmed on ultrasound or MRI)
- cord blood acidemia (umbilical artery gas pH <= 7.0 or base excess >= 12)
- Apgar <5 at 5 minutes
Measured: Measured up to 28 days of life for the newborn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start14 Nov 2018
- Primary completion26 Aug 2020
- Study completion13 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Preterm PregnancyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to early amniotomy (\<4cm cervical dilation) or late amniotomy (≥4cm dilated). Participants may crossover due due to clinical conditions that are not preventable. These conditions may include: unengaged vertex at time of attempted amniotomy, need for internal monitors, or cervical dilation that does not reach 4cm.
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay Speros Robbins, MD, MPH, University of Alabama at Birmingham
- Investigators
- Lindsay S Robbins, MD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504670
- Sponsor's protocol ID
- UAB_EarlyAROM
- Acronym
- PITA
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2018
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.
PubMed 28135188Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4.
PubMed 18177778Fraser WD, Marcoux S, Moutquin JM, Christen A. Effect of early amniotomy on the risk of dystocia in nulliparous women. The Canadian Early Amniotomy Study Group. N Engl J Med. 1993 Apr 22;328(16):1145-9. doi: 10.1056/NEJM199304223281602.
PubMed 8257472Gagnon-Gervais K, Bujold E, Iglesias MH, Duperron L, Masse A, Mayrand MH, Sansregret A, Fraser W, Audibert F. Early versus late amniotomy for labour induction: a randomized controlled trial. J Matern Fetal Neonatal Med. 2012 Nov;25(11):2326-9. doi: 10.3109/14767058.2012.695819. Epub 2012 Jun 13.
PubMed 22616980Macones GA, Cahill A, Stamilio DM, Odibo AO. The efficacy of early amniotomy in nulliparous labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):403.e1-5. doi: 10.1016/j.ajog.2012.08.032. Epub 2012 Aug 24.
PubMed 22959833Onah LN, Dim CC, Nwagha UI, Ozumba BC. Effect of early amniotomy on the outcome of spontaneous labour: a randomized controlled trial of pregnant women in Enugu, South-east Nigeria. Afr Health Sci. 2015 Dec;15(4):1097-103. doi: 10.4314/ahs.v15i4.7.
PubMed 26958009Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.
PubMed 27500341Parrish MM, Kuper SG, Jauk VC, Baalbaki SH, Tita AT, Harper LM. Does Early Artificial Rupture of Membranes Speed Labor in Preterm Inductions? Am J Perinatol. 2018 Jul;35(8):716-720. doi: 10.1055/s-0037-1612631. Epub 2017 Dec 14.
PubMed 29241279ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
PubMed 19623003Kuper SG, Sievert RA, Steele R, Biggio JR, Tita AT, Harper LM. Maternal and Neonatal Outcomes in Indicated Preterm Births Based on the Intended Mode of Delivery. Obstet Gynecol. 2017 Nov;130(5):1143-1151. doi: 10.1097/AOG.0000000000002320.
PubMed 29016494Cooney LG, Bastek JA. The Association between Early Artificial Amniotomy and Chorioamnionitis in Nulliparous Induction of Labor. Int Sch Res Notices. 2014 Dec 16;2014:628452. doi: 10.1155/2014/628452. eCollection 2014.
PubMed 27379338
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03504670
- Acronym / sponsor ID
- PITA / UAB_EarlyAROM
- Conditions
- Preterm Pregnancy, Labor Induction
- Keywords
- Labor induction, Cesarean delivery, Preterm labor induction, Duration of labor induction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 26 Aug 2020 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 20 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.
Artificial rupture of membranes (amniotomy) is a commonly used technique to safely induce and augment labor. It has been shown to reduce the duration of spontaneous and induced labor in term patients (≥37 weeks' gestation). The utility of amniotomy in preterm patients (<37 weeks' gestation) undergoing medically-indicated induction of labor is unknown. However, it remains a commonly used strategy. We will conduct a trial comparing early amniotomy versus late amniotomy during medically-indicated induction of labor between 23.0 and 35.6 weeks gestation. Women will be randomized to early or late amniotomy after the obstetrician has decided to induce labor for a medical indication. We hypothesize that more women in the early amniotomy group will require cesarean delivery, and the duration of labor will increase in the early amniotomy group.
Detailed description
The rate of preterm birth in the United States is nearly 10%. Up to one-third of these births are the result of a medically-indicated delivery. While induction of labor in women at term gestation has been extensively studied, the same is not true for preterm gestations. Consequently, the same methods of labor induction are used in term and preterm gestations, although preterm gestations may have different responses to induction agents compared to term gestations.
At our institution, a standard induction of labor - for term or preterm women - is performed using a cervical Foley catheter or misoprostol for cervical ripening with the addition of intravenous oxytocin for labor augmentation. As membranes do not typically spontaneously rupture during the induction process, amniotomy is commonly utilized by providers to help augment labor. Amniotomy releases prostaglandin-rich amniotic fluid. These prostaglandins are important mediators of uterine contractility and ultimately active labor. It has been shown to reduce the duration of spontaneous and induced labor in term patients.
The timing of amniotomy is left up to the discretion of the treating providers, as there are no randomized controlled trials to support early versus late amniotomy at preterm gestations. However, a retrospective cohort of nulliparous and multiparous women at our institution undergoing induction at 23-34 weeks, and evaluating early amniotomy at <4cm cervical dilation versus late amniotomy at ≥4cm dilation, showed an increased risk of cesarean delivery and increased time from start of induction to delivery for early amniotomy, although only the cesarean delivery outcome was significant after adjusting for confounders.
We will conduct an intention-to-treat randomized controlled trial comparing early amniotomy versus late amniotomy during medically-indicated induction of labor between 23.0 and 35.6 weeks gestation. Women will be randomized to early or late amniotomy after the attending obstetrician has decided to induce labor for a medical indication. Early amniotomy will be performed prior to 4cm cervical dilation being reached. Late amniotomy will be performed at greater than or equal to 4cm cervical dilation.
The purpose of this study is to determine whether timing of amniotomy during medically-indicated preterm induction of labor affects labor outcomes. We will specifically be looking at risk of cesarean delivery, duration of labor, maternal morbidity, and neonatal morbidity. We hypothesize that more women in the early amniotomy group will require cesarean delivery and that the duration of labor will increase in the early amniotomy group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to early amniotomy (<4cm cervical dilation) or late amniotomy (≥4cm dilated). Participants may crossover due due to clinical conditions that are not preventable. These conditions may include: unengaged vertex at time of attempted amniotomy, need for internal monitors, or cervical dilation that does not reach 4cm.
| Arm | Type | Receives |
|---|---|---|
| Early amniotomy | Experimental | Procedure: Early AmniotomyWomen randomized to early amniotomy will have their membranes ruptured in usual fashion using an amniotomy hook when the cervix is less than 4cm dilated. This will occur after cervical ripening has taken place, with 1) a cervical Foley balloon catheter with or without oxytocin and/or 2) misoprostol. Prior to amniotomy, the obstetric provider will assess whether or not the fetal head is engaged. If the fetal head is not engaged (applied to the cervix), amniotomy will be deferred. The patient will be examined every 2 hours until amniotomy can be safely performed (in keeping with our institutional standard of care to examine women every 2-4 hours in labor). |
| Late amniotomy | Experimental | Procedure: Late AmniotomyWomen randomized to late amniotomy will have their membranes ruptured once the cervix reaches at least 4cm dilation. This will occur after cervical ripening has taken place, with 1) a cervical Foley balloon catheter with or without oxytocin and/or 2) misoprostol. If the cervix fails to reach 4cm dilation 12 hours following cervical ripening, amniotomy will be performed. |
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)
- Singleton gestation
- Gestational age at randomization between 23.0 and 35.6 weeks
- Induction of labor planned for maternal or fetal indications
- Reassuring fetal status
- Vertex presentation
Key exclusion criteria (10 listed)
- Plan for cesarean delivery or contraindication to labor
- Cervix ≥4cm dilated at start of induction
- Signs of spontaneous labor (active contractions with cervical change)
- Ruptured membranes
- Chorioamnionitis
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 |
|---|---|---|
| Early AmniotomyThis intervention involves using an amniotomy hook to rupture the membranes during a sterile vaginal exam. This intervention will be performed prior to the cervix being dilated 4cm. | Procedure or surgery | Early amniotomy |
| Late AmniotomyThis intervention involves using an amniotomy hook to rupture the membranes during a sterile vaginal exam. This intervention will be performed once the cervix is at least 4cm dilated. | Procedure or surgery | Late amniotomy |
Primary outcome
Cesarean delivery
Time frame: Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.
Proportion of women requiring cesarean delivery
4 secondary outcomes
Interval from induction onset to delivery
Time frame: Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.
Interval from induction onset to vaginal delivery
Time frame: Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.
Composite maternal morbidity
Time frame: Measured from start of induction of labor up to 42 days following delivery
Composite neonatal morbidity
Time frame: Measured up to 28 days of life for the newborn
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 27 Apr 2021.
- Background: PubMed 28135188Martin JA, Hamilton BE, Osterman MJ, Driscoll AK, Mathews TJ. Births: Final Data for 2015. Natl Vital Stat Rep. 2017 Jan;66(1):1.
- Background: PubMed 18177778Goldenberg RL, Culhane JF, Iams JD, Romero R. Epidemiology and causes of preterm birth. Lancet. 2008 Jan 5;371(9606):75-84. doi: 10.1016/S0140-6736(08)60074-4.
- Background: PubMed 8257472Fraser WD, Marcoux S, Moutquin JM, Christen A. Effect of early amniotomy on the risk of dystocia in nulliparous women. The Canadian Early Amniotomy Study Group. N Engl J Med. 1993 Apr 22;328(16):1145-9. doi: 10.1056/NEJM199304223281602.
- Background: PubMed 22616980Gagnon-Gervais K, Bujold E, Iglesias MH, Duperron L, Masse A, Mayrand MH, Sansregret A, Fraser W, Audibert F. Early versus late amniotomy for labour induction: a randomized controlled trial. J Matern Fetal Neonatal Med. 2012 Nov;25(11):2326-9. doi: 10.3109/14767058.2012.695819. Epub 2012 Jun 13.
- Background: PubMed 22959833Macones GA, Cahill A, Stamilio DM, Odibo AO. The efficacy of early amniotomy in nulliparous labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):403.e1-5. doi: 10.1016/j.ajog.2012.08.032. Epub 2012 Aug 24.
- Background: PubMed 26958009Onah LN, Dim CC, Nwagha UI, Ozumba BC. Effect of early amniotomy on the outcome of spontaneous labour: a randomized controlled trial of pregnant women in Enugu, South-east Nigeria. Afr Health Sci. 2015 Dec;15(4):1097-103. doi: 10.4314/ahs.v15i4.7.
- Background: PubMed 27500341Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.
- Background: PubMed 29241279Parrish MM, Kuper SG, Jauk VC, Baalbaki SH, Tita AT, Harper LM. Does Early Artificial Rupture of Membranes Speed Labor in Preterm Inductions? Am J Perinatol. 2018 Jul;35(8):716-720. doi: 10.1055/s-0037-1612631. Epub 2017 Dec 14.
- Background: PubMed 19623003ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
- Background: PubMed 29016494Kuper SG, Sievert RA, Steele R, Biggio JR, Tita AT, Harper LM. Maternal and Neonatal Outcomes in Indicated Preterm Births Based on the Intended Mode of Delivery. Obstet Gynecol. 2017 Nov;130(5):1143-1151. doi: 10.1097/AOG.0000000000002320.
- Background: PubMed 27379338Cooney LG, Bastek JA. The Association between Early Artificial Amniotomy and Chorioamnionitis in Nulliparous Induction of Labor. Int Sch Res Notices. 2014 Dec 16;2014:628452. doi: 10.1155/2014/628452. eCollection 2014.
- Individual participant dataSharing planned: Undecided
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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.
Lindsay S Robbins, MD, MPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Amniotomy and Late Amniotomy in people with Preterm Pregnancy and Labor Induction, run by University of Alabama at Birmingham at 1 site in United States.
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 10 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 27 Apr 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 United States. 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?
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?
Cesarean delivery (time frame: Duration is dependent upon the length of labor. The maximum time frame would be anticipated to be 120 hours from start of the induction.). 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 NCT03504670, which also lists 11 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 27 Apr 2021.