Randomized trial of intravaginal gel, intravaginal time release insert, and intracervical gel with prostaglandin e2 for induction of labor

A. Duhl, Jorge Tolosa, M. Leiva, R. Nemtrof

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

OBJECTIVE: To compare three presentations of proslaglandin (PG) E2 for induction of labor. STUDY DESIGN: 74 women with a medical indication for inpatiem induction oflabor were randomi/ed to receive 3 mg PGE2 intravaginal gel every 4 to (i hrs (group 1). 10 ing time release intravaginal insert with dinoprostone, Cervidil®, every 12 hrs (group 2). or 0.5 nig intracervical dinoprostone, Prepidil® gel, every 6 hrs (group 3) until intravenous oxvtocin was started. Change in Bishop score prior to starting oxytocin and complications (uterine hyperslimulation, decelerations) were compared using AN OVA, t-test, and Fisher's exact test, stratified by paritv. Analvsis was inducted blindly to group assignment. RESULTS: 24 subjects were in group 1. 27 in group 2, and 23 in group 3. Distribution by race: white n = 30 (40%), black n = 39 (53%), other n = 5 (7%); 48 (65%) were nulliparons and 26 (35%) were inultiparous. Induction was started at a gestational age (GA) >36 wks in 95% (n - 70). GA uas determined by a second trimester ultrasound in 73/74 and 9/74 (12%) were VBAC. All three treatment groups effectively improved the Bishop scores in both nnlliparous and inultiparous patients (p <0.005). In the inultiparous women, treatment (2). (Cervidil®), demonstrated to be the most effective (p 0.036) and laboi was initiated more frequently, not needing augmentation with Pitocin (RR: 0.15; 95% CI (0.04, 0.58); p = 0.001). I'terine hvpcrstimnlation was seen in 2/24 (group 1). 5/27 (group 2). and 2/23 (group 3), (p = 0.53). CONCLUSIONS: The time release intravaginal insert with dinoprostone appears to be a more effective agent to ripen the cervix and induce labor in this pilot RCT. I'terine hyperstiniulation resulting from its use needs to befurther studied.

Original languageEnglish (US)
JournalActa Diabetologica Latina
Volume176
Issue number1 PART II
StatePublished - 1997
Externally publishedYes

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Induced Labor
Dinoprostone
Gels
Oxytocin
Gestational Age
Deceleration
Second Pregnancy Trimester
Cervix Uteri
Therapeutics

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology
  • Endocrinology, Diabetes and Metabolism

Cite this

Randomized trial of intravaginal gel, intravaginal time release insert, and intracervical gel with prostaglandin e2 for induction of labor. / Duhl, A.; Tolosa, Jorge; Leiva, M.; Nemtrof, R.

In: Acta Diabetologica Latina, Vol. 176, No. 1 PART II, 1997.

Research output: Contribution to journalArticle

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abstract = "OBJECTIVE: To compare three presentations of proslaglandin (PG) E2 for induction of labor. STUDY DESIGN: 74 women with a medical indication for inpatiem induction oflabor were randomi/ed to receive 3 mg PGE2 intravaginal gel every 4 to (i hrs (group 1). 10 ing time release intravaginal insert with dinoprostone, Cervidil{\circledR}, every 12 hrs (group 2). or 0.5 nig intracervical dinoprostone, Prepidil{\circledR} gel, every 6 hrs (group 3) until intravenous oxvtocin was started. Change in Bishop score prior to starting oxytocin and complications (uterine hyperslimulation, decelerations) were compared using AN OVA, t-test, and Fisher's exact test, stratified by paritv. Analvsis was inducted blindly to group assignment. RESULTS: 24 subjects were in group 1. 27 in group 2, and 23 in group 3. Distribution by race: white n = 30 (40{\%}), black n = 39 (53{\%}), other n = 5 (7{\%}); 48 (65{\%}) were nulliparons and 26 (35{\%}) were inultiparous. Induction was started at a gestational age (GA) >36 wks in 95{\%} (n - 70). GA uas determined by a second trimester ultrasound in 73/74 and 9/74 (12{\%}) were VBAC. All three treatment groups effectively improved the Bishop scores in both nnlliparous and inultiparous patients (p <0.005). In the inultiparous women, treatment (2). (Cervidil{\circledR}), demonstrated to be the most effective (p 0.036) and laboi was initiated more frequently, not needing augmentation with Pitocin (RR: 0.15; 95{\%} CI (0.04, 0.58); p = 0.001). I'terine hvpcrstimnlation was seen in 2/24 (group 1). 5/27 (group 2). and 2/23 (group 3), (p = 0.53). CONCLUSIONS: The time release intravaginal insert with dinoprostone appears to be a more effective agent to ripen the cervix and induce labor in this pilot RCT. I'terine hyperstiniulation resulting from its use needs to befurther studied.",
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AU - Nemtrof, R.

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N2 - OBJECTIVE: To compare three presentations of proslaglandin (PG) E2 for induction of labor. STUDY DESIGN: 74 women with a medical indication for inpatiem induction oflabor were randomi/ed to receive 3 mg PGE2 intravaginal gel every 4 to (i hrs (group 1). 10 ing time release intravaginal insert with dinoprostone, Cervidil®, every 12 hrs (group 2). or 0.5 nig intracervical dinoprostone, Prepidil® gel, every 6 hrs (group 3) until intravenous oxvtocin was started. Change in Bishop score prior to starting oxytocin and complications (uterine hyperslimulation, decelerations) were compared using AN OVA, t-test, and Fisher's exact test, stratified by paritv. Analvsis was inducted blindly to group assignment. RESULTS: 24 subjects were in group 1. 27 in group 2, and 23 in group 3. Distribution by race: white n = 30 (40%), black n = 39 (53%), other n = 5 (7%); 48 (65%) were nulliparons and 26 (35%) were inultiparous. Induction was started at a gestational age (GA) >36 wks in 95% (n - 70). GA uas determined by a second trimester ultrasound in 73/74 and 9/74 (12%) were VBAC. All three treatment groups effectively improved the Bishop scores in both nnlliparous and inultiparous patients (p <0.005). In the inultiparous women, treatment (2). (Cervidil®), demonstrated to be the most effective (p 0.036) and laboi was initiated more frequently, not needing augmentation with Pitocin (RR: 0.15; 95% CI (0.04, 0.58); p = 0.001). I'terine hvpcrstimnlation was seen in 2/24 (group 1). 5/27 (group 2). and 2/23 (group 3), (p = 0.53). CONCLUSIONS: The time release intravaginal insert with dinoprostone appears to be a more effective agent to ripen the cervix and induce labor in this pilot RCT. I'terine hyperstiniulation resulting from its use needs to befurther studied.

AB - OBJECTIVE: To compare three presentations of proslaglandin (PG) E2 for induction of labor. STUDY DESIGN: 74 women with a medical indication for inpatiem induction oflabor were randomi/ed to receive 3 mg PGE2 intravaginal gel every 4 to (i hrs (group 1). 10 ing time release intravaginal insert with dinoprostone, Cervidil®, every 12 hrs (group 2). or 0.5 nig intracervical dinoprostone, Prepidil® gel, every 6 hrs (group 3) until intravenous oxvtocin was started. Change in Bishop score prior to starting oxytocin and complications (uterine hyperslimulation, decelerations) were compared using AN OVA, t-test, and Fisher's exact test, stratified by paritv. Analvsis was inducted blindly to group assignment. RESULTS: 24 subjects were in group 1. 27 in group 2, and 23 in group 3. Distribution by race: white n = 30 (40%), black n = 39 (53%), other n = 5 (7%); 48 (65%) were nulliparons and 26 (35%) were inultiparous. Induction was started at a gestational age (GA) >36 wks in 95% (n - 70). GA uas determined by a second trimester ultrasound in 73/74 and 9/74 (12%) were VBAC. All three treatment groups effectively improved the Bishop scores in both nnlliparous and inultiparous patients (p <0.005). In the inultiparous women, treatment (2). (Cervidil®), demonstrated to be the most effective (p 0.036) and laboi was initiated more frequently, not needing augmentation with Pitocin (RR: 0.15; 95% CI (0.04, 0.58); p = 0.001). I'terine hvpcrstimnlation was seen in 2/24 (group 1). 5/27 (group 2). and 2/23 (group 3), (p = 0.53). CONCLUSIONS: The time release intravaginal insert with dinoprostone appears to be a more effective agent to ripen the cervix and induce labor in this pilot RCT. I'terine hyperstiniulation resulting from its use needs to befurther studied.

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