A substantive amendment to this systematic review was last made on 28 August 1996. Cochrane reviews are regularly checked and updated if necessary.Prelabour rupture of membranes (PROM) occurs in approximately 6 to 19 percent of all term births (Grant et al 1989). Althougth its occurrence is not uncommon, there exists much confusion with regard to the most appropriate course of management. Immediate induction of labour has been advocated to possibly reduce the risk of neonatal infection (Burchell 1964). For labour that is induced, the traditional method of induction is with intravenous oxytocin. This management plan, however, has been associated with a significant increase in the incidence of instrumental deliveries and Caesarean section in some studies (Duff et al 1984). More recently, induction with prostaglandins, followed by an infusion of oxytocin if necessary, has been used. It is not known as to which is the better method. A more expectant approach has also become popular during the past decade and some studies suggest that this approach is less likely to be associated with need for Caesarean section (Morales et al 1986). While PROM is not a new clinical problem, the management remains controversial: Induction of labour with oxytocin or induction of labour with prostaglandins or expectant care?Background and objectives: The conventional method of induction of labour is with intravenous oxytocin. More recently, induction with prostaglandins, followed by an infusion of oxytocin if necessary, has been used. The objective of this review was to assess the effects of induction of labour with prostaglandins compared with oxytocin, at or near term.
Search strategy: We searched the Cochrane Pregnancy and Childbirth Group trials register.
Selection criteria: Randomised and quasi-randomised trials of early stimulation of uterine contractions with prostaglandins (with or without oxytocin) versus with oxytocin alone (not combined with prostaglandins) in women with spontaneous rupture of membranes before labour (34 weeks or more gestation).
Data collection and analysis: Two reviewers assessed trial quality and extracted data.
Main results: Seventeen trials were included. Most of the trials were of moderate to good quality. Based on six trials, prostaglandins compared with oxytocin were associated with increased chorioamnionitis (odds ratio of 1.49, 95% confidence interval 1.07 to 2.09) and maternal nausea/vomiting. Based on eight trials, prostaglandins were associated with a decrease in epidural analgesia, odds ratio of 0.85, 95% confidence interval 0.73 to 0.98 and internal fetal heart rate monitoring (based on one trial). Caesarean section, endometritis and perinatal mortality were not significantly different between the groups.
Reviewers conclusions: Women with prelabour rupture of membranes at or near term having their labour induced with prostaglandins appear to have a lower risk of epidural analgesia and fetal heart rate monitoring. However there appears to be an increased risk of chorioamnionitis and nausea/vomiting with prostaglandins compared to oxytocin.
(This abstract has been prepared centrally.)
See: Collaborative Review Group search strategy
This Review has drawn on the search strategy developed for the Pregnancy and Childbirth Group as a whole.Relevant trials were identified in the Group s Specialised Register of Controlled Trials. See Review Group s details for more information.
See Search Strategy.It is not known, in any of the trials, whether the presence of maternal or neonatal infection was assessed in a similar and consistent fashion for all mothers and babies, without knowledge of the group of allocation or the duration of membrane rupture.
Induction of labour with prostaglandins increases the risk of maternal infection (chorioamnionitis), maternal side effects (nausea and/or vomiting), maternal interventions (numerous vaginal examinations; >8) and may also increase the risk of neonatal infection compared to induction of labour with oxytocin. Search for, and the determination of, neonatal infection was not conducted blinded to allocation group and duration of membrane rupture in any but the Hannah trial; the harmful effect of induction of labour with prostaglandins on this outcome may be less than suggested by this meta-analysis. Induction of labour with prostaglandins increases the rate of neonatal antibiotic therapy and admission to neonatal intensive care.
There is no evidence from high quality trials that a policy of induction of labour with prostaglandins increases or decreases the rate of Caesarean section, although it is associated with a less frequent use of epidural analgesia and internal fetal heart rate monitoring.
The trials included in this meta-analysis used different forms of prostaglandins. It may be inappropriate to combine these trials together. The results should therefore be interpreted with caution. The results, however, are consistent with the results of other reviews of active management for prelabour rupture of the membranes: see Reviews of Oxytocin for prelabour rupture of the membranes at or near term, and Prostaglandins for prelabour rupture of the membranes at or near term.References to studies included in this review
Chua 1991 (published data only) Chua S, Arulkumaran S, Kurup A, Anandakumar C, Tay D, Ratnam SS. Does prostaglandin confer significant advantage over oxytocin infusion for nulliparas with pre-labour rupture of membranes at term? Obstet Gynecol. 1991; 77: 664-667. Ekman-Ordeberg 1985 (published data only) Ekman-Ordeberg G, Uldbjerg N, Ulmsten U. Comparison of intravenous oxytocin and vaginal prostaglandin E2 gel in women with unripe cervixes and premature rupture of the membranes. Obstet Gynecol 1985; 66: 307-310. El-Qarmalawi 1990 (published data only) El-Qarmalawi AM, Elmardi AA, Saddik M, El-Abdel Hadi F, Shaker SMA. A comparative randomized study of oral prostaglandin E2 (PGE2) tablets and intravenous oxytocin in induction of labour in patients with premature rupture of membranes before 37 weeks of pregnancy. Int J Gynecol Obstet 1990; 33: 115-119. Goeschen 1989 (published data only) Goeschen K. Premature rupture of membranes near term: induction of labour with endocervical prostaglandin E2 gel or intravenous oxytocin. Am J Perinatol 1989; 6: 181-184. Hannah 1996 (published and unpublished data) Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EEL, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of membranes at term. N Engl J Med 1996; 334: 1005-10. Lange 1981 (published data only) Lange AP, Secher NJ, Nielsen FH, Pedersen GT. Stimulation of labour in cases of premature rupture of the membranes at or near term. Acta Obstet Gynecol Scand 1981; 60: 207-210. MacLennan 1980 (published data only) MacLennan AH, Green RC. The effect of intravaginal prostaglandin F2alpha on labour after spontaneous and artificial rupture of the membranes. Aust NZ J Obstet Gynaecol 1980; 20: 87-90. Magos 1983 (published data only) Magos AL, Noble MCB, Yuen AWT, Rodeck CH. Controlled study comparing vaginal prostaglandin E2 pessaries with intravenous oxytocin for the stimulation of labour after spontaneous rupture of the membranes. Br J Obstet Gynaecol 1983; 90: 726-731. Massil 1988 (published data only) Massil HY, Baker AC, O Brien PMS. A comparison of oral prostaglandin E2 tablets with intravenous oxytocin for stimulation of labour after premature rupture of membranes at term. Acta Obstet Gynecol Scand 1988; 67: 703-709. McQueen 1990 (published data only) McQueen D, Neilson JP, Whittle MJ. Pre-labour rupture of membranes with an unripe cervix: a random trial of management. J Obstet Gynaecol 1990; 10: 495-498. Moller 1987 (published data only) Moller M, Thomsen AC, Sorensen J, Forman A. Oxytocin- or low-dose prostaglandin F2alpha-infusion for stimulation of labour after primary rupture of membranes. Acta Obstet Gynecol Scand 1987; 66: 103-106. Ray 1992 (published data only) Ray DA, Garite TJ. Prostaglandin E2 for induction of labour in patients with premature rupture of membranes at term. Am J Obstet Gynecol 1992; 166: 836-843. Ray DA, Garite TJ. Prostoglandin E2 for induction in term patients with premature rupture of membranes. Proceedings of 10th Annual Meeting of Society of Perinatal Obstetricians, Houston, Texas, U.S.A. 1990; 80. (5359): -. Rymer 1992 (published data only) Rymer J, Parker A. A comparison of syntocinon infusion with prostaglandin vaginal pessaries when spontaneous rupture of the membranes occurs without labour after 34 weeks gestation. Aust NZ J Obstet Gynaecol 1992; 32: 22-24. Sanchez-Ramos 1994 (published data only) Sanchez-Ramos L, Chen A, Briones D, DelValle GO, Gaudier FL, Delke I. Premature rupture of membranes at. term; : induction-. Van der Walt 1989 (published data only) Van der Walt D, Venter PF. Management of term pregnancy with premature rupture of the membranes and unfavourable cervix. S Afr Med J 1989; 75: 54-56. Westergaard 1983 (published data only) Westergaard JG, Lange AP, Pedersen GT, Secher NJ. Use of oral oxytocics for stimulation of labour in cases of premature rupture of the membranes at term. Acta Obstet Gynecol Scand 1983; 62: 111-116. * indicates the major publication for the study References to studies excluded from this review Borisov 1985 Borisov I, Starkalev I. Comparison of oral PGE2 and intravenous oxytocin for stimulation of labour in cases of premature rupture of the membranes. FIGO 1985 (Abstract #12.42.07). (610; : -. Day 1985 Day A, MacLennan A, Green R. A comparison of intravaginal PGF2alpha and intravenous oxytocin to stimulate labour after membrane rupture. Aust NZ J Obstet Gynaecol 1985; 25: 252-5. Griffith-Jones 1990 Griffith-Jones MD, Tyrrell SN, Tuffnell DJ. A prospective trial comparing intravenous oxytocin with vaginal prostaglandin E2 tablets for labour induction in cases of spontaneous rupture of the membranes. Obstet Gynaecol Today 1990; 1(4): 104-5. McCaul 1992 McCaul JF, Williams LM, Martin RW, Magann EF, Gallagher L, Morrison JC. Comparison of induction methods for premature rupture of membranes at term. Am J Obstet Gynecol 1992; 166: 275 (Abstr-. Vernant 1993 Vernant M, Perez-Picanol E, Armengol R, Carreras N, Gamissans O. Intracervical prostaglandin vs oxytocin in premature rupture of membranes. Second World Congress of Perinatal Medicine, Rome, 1993; (Abstract #16). (7962): -. Additional references Burchell 1964 Burchell RC. Premature spontaneous rupture of membranes. Am J Obstet Gynecol 1964; 88: 251-255. Duff et al 1984 Duff P, Huff RW, Gibbs RS. Management of premature rupture of membranes and unfavourable cervix in term pregnancy. Obstet Gynecol 1984; 63: 697-702. Grant et al 1989 Grant J, Keirse MJNC. Prelabour rupture of the membranes at term. In: Chalmers I, Enkin M, Keirse MJNC (eds). Effective Care in Pregnancy and Childbirth. Oxfo; : Oxford Uni-1117. Morales et al 1986 Morales WJ, Lazar AJ. Expectant management of rupture of membranes at term. S Med J 1986; 79(8): 955-958. Extramural sources of support to the review Intramural sources of support to the review Fig 02 PROSTAGLANDINS VS OXYTOCIN FOR PRELABOUR RUPTURE OF MEMBRANES AT 34+ WEEKS (NULLIPARAS) Fig 03 PROSTAGLANDINS VS OXYTOCIN FOR PRELABOUR RUPTURE OF MEMBRANES AT 34+ WEEKS (MULTIPARAS) Fig 04 PROSTAGLANDINS VS OXYTOCIN FOR PRELABOUR RUPTURE OF MEMBRANES >34 WEEKS - HIGH QUALITY TRIALS Reviewer(s) Tan BP, Hannah ME Date of most recent amendment 26 February 1999 Date of most recent substantive amendment 28 August 1996 Contact address Dr Brenda Tan
Suite 406
988 West 21st Avenue
Vancouver
British Colombia
Canada
V5Z 1Z1
Telephone: +1 604 738 8884
Facsimile:
E-mail: bptan@interchange.ubc.caCochrane Library number CD000158 Editorial group Cochrane Pregnancy and Childbirth Group Editorial group code HM-PREG This review should be cited as :
Tan BP, Hannah ME. Prostaglandins versus oxytocin for prelabour rupture of membranes at or near term (Cochrane Review). In: The Cochrane Library, Issue 2, 1999. Oxford: Update Software.Sources of support
Keywords
PROSTAGLANDINS / therapeutic-use; OXYTOCIN / therapeutic-use; FETAL-MEMBRANES-PREMATURE-RUPTURE / drug-therapy; LABOR-INDUCED; PREGNANCY-TRIMESTER-THIRD; PREGNANCY; HUMAN; FEMALE; INFANT-NEWBORN; COMPARATIVE-STUDY; DRUG-THERAPY-COMBINATION; CESAREAN-SECTION; TREATMENT-OUTCOME; CONTROLLED-CLINICAL-TRIALS; META-ANALYSIS; RISK-FACTORSList of comparisons
Fig 01 PROSTAGLANDINS VS OXYTOCIN FOR PRELABOUR RUPTURE OF MEMBRANES AT 34+ WEEKS
Tables of other data
Tables of other data are not available for this review
| Study | Method | Participants | Interventions | Outcomes | Notes |
|---|---|---|---|---|---|
| Chua 1991 | Sealed envelopes. | >= 36 weeks Nulliparous Unripe cervix ROM > 2 hours | PG Group: Vaginal PGE2 3mg 4 hourly x 1, then IV oxytocin. Oxytocin Group: IV oxytocin. | Caesarean section, Chorioamnionitis, Endometritis, Neonatal infection, Admission to the NICU, Caesarean section for fetal distress, Caesarean section for failed induction, Operative delivery, Fetal distress. | |
| Ekman-Ordeberg 1985 | Not stated. | Term Unripe cervix Nulliparous | PG Group: Vaginal PGE2 4mg repeated once if necessary after 24 hours. Oxytocin Group: IV oxytocin. | Caesarean section, Endometritis, Hypertonus, Apgar < 7 at 5 minutes, Caesarean section for fetal distress, Caesarean section for dystocia, Operative delivery, Nausea/vomiting. | |
| El-Qarmalawi 1990 | Not stated. | 34-36 weeks ROM x 3 hours | PG Group: Oral PGE2 0.5mg x 6 hours. Oxytocin Group: IV oxytocin x 6 hours. | Caesarean section, Endometritis, Caesarean section for fetal distress, Caesarean section for dystocia, Caesarean section for failed induction, Hypertonus, Nausea/vomiting. | |
| Goeschen 1989 | Not stated. | >= 36 weeks Unripe cervix ROM x 10 hours | PG Group: Endocervical PGE2 0.4mg daily. Oxytocin Group: IV Oxytocin. | Caesarean section, Chorioamnionitis, Operative delivery, Apgar < 7 at 5 minutes. | |
| Hannah 1996 | Touch-tone telephone access to computerized randomization program. | >= 37 weeks Singleton Cephalic | PG Group: Vaginal PGE2, 1 or 2mg, reapplied 6 hours later if no labour, oxytocin 4 hours later if no labour. Oxytocin Group: Infusion rates titrated to contractions according to local hospital practice. | PUBLISHED OUTCOMES: Maternal: Internal fetal heart monitoring, Fetal distress, Meconium-stained amniotic fluid, Chorioamnionitis, Antibiotics before/during labour, Cord prolapse, Caesarean section, Operative vaginal delivery, Spontaneous vaginal delivery, Post-partum fever, Analgesia, No anesthesia/analgesia, Number of Digital vaginal exams: <4, Number of Digital vaginal exams: 4-8, Number of Digital vaginal exams: >8, Disliked treatment, If had to do it over again, would participate in study. Perinatal: Deaths not including major congenital anomalies. Neonatal: Infection, Apgar <7 at 1 minute, Apgar <7 at 5 minutes, Cord pH <7.10, Resuscitation with oxygen, Jitteriness or irritability, Seizures, Hypotonia, Abnormal level of consciousness, Apnea, Abnormal feeding >= 48 hours, Ventilation after initial resuscitation, Antibiotics, Admission to NICU > 24 hours. UNPUBLISHED OUTCOMES: | |
| Lange 1981 | Not stated. | Term Unripe cervix ROM x 6 hours | PG Group: Oral PGE2 0.5-1.5mg hourly, with IV oxytocin later as required. Oxytocin Group: IV oxytocin. | Caesarean section, Caesarean section for dystocia, Operative delivery, Epidural, Cord prolapse, Perinatal death. | |
| MacLennan 1980 | Sealed envelopes. | Term | PG Group: Vaginal PGF2alpha 50mg, IV oxytocin 4 hours later. Oxytocin Group: IV oxytocin. | Caesarean section, Epidural analgesia, Operative delivery, Neonatal jaundice. | |
| Magos 1983 | Hospital number. | > 34 weeks ROM x 4 hours | PG Group: Vaginal PGE2 3mg 4 hourly x 1, IV oxytocin 4 hours later. Oxytocin Group: IV oxytocin. | Caesarean section, Epidural analgesia, Chorioamnionitis, Endometritis, Hypertonus, Apgar < 7 at 1 minute, Apgar < 7 at 5 minutes, Admission to the NICU, Operative delivery, Neonatal jaundice. | |
| Massil 1988 | Not stated. | > 36 weeks ROM x 12 hours | PG Group: Oral PGE2 0.5-1mg x 8 hours, then IV oxytocin as required. Oxytocin Group: IV oxytocin. | Caesarean section, Epidural analgesia, Neonatal infection, Hypertonus, Admisssion to the NICU, Operative delivery, Postpartum haemorrhage, Nausea/vomiting, Patient disliked method, Neonatal jaundice. | |
| McQueen 1990 | Sealed envelopes. | >= 37 weeks Nulliparous Unripe cervix ROM x 2-12 hours | PG Group: Vaginal PGE2 3mg repeated once after 24 hours if necessary. Oxytocin Group: IV oxytocin. | Caesarean section, Epidural analgesia, Chorioamnionitis, Endometritis, Neonatal infection, Apgar score < 7 at 1 minute, Apgar score < 7 at 5 minutes, Operative delivery. | |
| Moller 1987 | Not stated. | 37-43 weeks ROM x 6 hours | PG Group: IV PGF2alpha x 8 hours, repeat 24 hours later as required. Oxytocin Group: IV oxytocin. | Caesarean section, Hypertonus, Diarrhea, Nausea/vomiting, Operative delivery, Apgar <7 at 5 minutes. | |
| Ray 1992 | Telephone communication. | > 36 weeks | PG Group: Vaginal PGE2 3mg 6 hourly x 2, then IV oxytocin. Oxytocin Group: IV oxytocin. | Caesarean section, Chorioamnionitis, Endometritis, Neonatal infection, Caesarean section for dystocia, Hypertonus, Nausea/vomiting, Apgar <7 at 5 minutes, Admission to NICU. | |
| Rymer 1992 | Sealed envelopes. | >= 34 weeks ROM >= 4 hours | PG Group: Vaginal PGE2 1-3mg 1-3 hourly x 3, then IV oxytocin 8 hours later. Oxytocin Group: IV oxytocin. | Caesarean section, Epidural analgesia, Neonatal infection, Hypertonus, Admission to the NICU, Operative delivery. | |
| Sanchez-Ramos 1994 | Sealed envelopes. | Term | PG Group: Intravaginal misoprostol tablets (PGE1 analog) 50 mcg. Oxytocin Group: IV oxytocin. | Caesarean section. | |
| Van der Walt 1989 | Open list of random numbers. | >= 36 weeks Unripe cervix | PG Group: Vaginal PGE2 1mg 6 hourly x 3. Oxytocin Group: IV oxytocin. | Caesarean section, Endometritis, Neonatal infection, Epidural analgesia, Perinatal death. | |
| Westergaard 1983 | Not stated. | > 37 weeks Unripe cervix ROM x 6 hours | PG Group: Oral PGE2 0.5-1.5mg hourly x 8 hours, then IV oxytocin. Oxytocin Group: Demoxytocin tablets x 8 hours, then IV oxytocin. | Caesarean section, Hypertonus, Apgar < 7 at 5 minutes, Diarrhea, Nausea/vomiting, Caesarean section for fetal distress, Caesarean section for dystocia, Operative delivery, Postpartum haemorrhage, Apgar <7 at 1 minute, Perinatal death. |
| Study | Reason for exclusion |
|---|---|
| Borisov 1985 | No usable outcomes available. |
| Day 1985 | No usable outcomes available. |
| Griffith-Jones 1990 | No usable outcomes available. |
| McCaul 1992 | No usable outcomes available. |
| Vernant 1993 | No information regarding gestational age at randomization. |