Labor Induction Clinical Trial
— PITAOfficial title:
Preterm Induction of Labor Timing of Amniotomy: A Randomized Controlled Trial
Verified date | April 2021 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 86 |
Est. completion date | January 13, 2021 |
Est. primary completion date | August 26, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmigham, Women and Infants' Center | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. Review. — View Citation
Battarbee 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. — View Citation
Cooney 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. — View Citation
Fraser 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. — View Citation
Gagnon-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. — View Citation
Goldenberg 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. Review. — View Citation
Kuper 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. — View Citation
Macones 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. — View Citation
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Parrish 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cesarean delivery | Proportion of women requiring cesarean delivery | 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 | Interval from induction onset to delivery | Time (hours) from the start of induction (initiation of first cervical ripening agent) to delivery (vaginal or cesarean) | 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 | Interval from induction onset to vaginal delivery | Time (hours) from the start of induction (initiation of first cervical ripening agent) to vaginal delivery only | 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 | 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 from start of induction of labor up to 42 days following delivery | |
Secondary | 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 up to 28 days of life for the newborn |
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