Nitric oxide donors for cervical ripening in first‐trimester surgical abortion

Patama Promsonthi; Anyarin Preechapornprasert; Boonsri Chanrachakul

doi:10.1002/14651858.CD007444.pub4

Fármacos que liberan óxido nítrico para la maduración cervical en el aborto quirúrgico del primer trimestre

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Referencias

Referencias de los estudios incluidos en esta revisión

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estudios excluidos
otras referencias

Arteaga‐Troncoso G, Villegas‐Alvarado A, Belmont‐Gomez A, Martinez‐Herrera FJ, Villagrana‐Zesati R, Guerra‐Infante F. Intracervical application of the nitric oxide donor isosorbide dinitrate for induction of cervical ripening: a randomised controlled trial to determine clinical efficacy and safety prior to first trimester surgical evacuation of retained products of conception. BJOG: an International Journal of Obstetrics and Gynaecology 2005;112(12):1615‐9.

Chan CCW, Tang OS, Ng EHY, Ho PC. Intracervical sodium nitroprusside versus vaginal misoprostol in first trimester surgical termination of pregnancy: a randomized double‐blinded controlled trial. Human Reproduction 2005;20(3):829‐33.

Facchinetti F, Piccinini F, Volpe A. Chemical ripening of the cervix with intracervical application of sodium nitroprusside: a randomized controlled trial. Human Reproduction 2000;15(10):2224‐7.

Ledingham MA, Thomson AJ, Lunan CB, Greer IA, Norman JE. A comparison of isosorbide mononitrate, misoprostol and combination therapy for first trimester pre‐operative cervical ripening: a randomised controlled trial. British Journal of Obstetrics and Gynaecology 2001;108(3):276‐80.

Li CFI, Chan CWC, Ho PC. A comparison of isosorbide mononitrate and misoprostol cervical ripening before suction evacuation. Obstetrics and Gynecology 2003;102(3):583‐8.

Phusaanantakul P, Promsonthi P, Chanrachakul B. Effect of isosorbide mononitrate for cervical ripening before surgical termination of pregnancy in the first trimester. International Journal of Gynaecology Obstetrics 2010;110(2):145‐8.

Radulovic N, Norstrom A, Ekerhovd E. Outpatient cervical ripening before first‐trimester surgical abortion: a comparison between misoprostol and isosorbide mononitrate. Acta Obstetricia et Gynecologica 2007;86(3):344‐8.

Thomson AJ, Lunan CB, Cameron AD, Cameron IT, Greer IA, Norman JE. Nitric oxide donors induce ripening of the human uterine cervix: a randomised controlled trial. British Journal of Obstetrics and Gynaecology 1997;104(9):1054‐7.

Thomson AJ, Lunan CB, Ledingham M, Howat RCL, Cameron IT, Greer IA, et al. Randomised trial of nitric oxide donor versus prostaglandin for cervical ripening before first‐trimester termination of pregnancy. The Lancet 1998;352(9134):1093‐6.

Referencias de los estudios excluidos de esta revisión

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estudios incluidos
otras referencias

Chen FCK, Bergann A, Krosse J, Merholz A, David M. Isosorbide mononitrate vaginal gel versus misoprostol vaginal gel versus Dilapan‐S for cervical ripening before first trimester curettage. European Journal of Obstetrics & Gynecology and Reproductive Biology 2008;138(2):176‐9.

David M, Chen FCK, Lichtenegger W. NO‐donor nitroglycerin versus prostaglandin gemeprost for cervical ripening in first trimester missed abortion. International Journal of Gynecology and Obstetrics 2003;83(1):71‐2.

David M, Chen FCK. Comparison of isosorbide mononitrate (Mono Mack) and misoprostol (Cytotec) for cervical ripening in the first trimester missed abortion. Archives of Gynecology and Obstetrics 2005;273(3):144‐5.

Duhan N, Gupta S, Dahiya K, Sirohiwal D, Rohilla S. Comparison of isosorbide mononitrate and misoprostol for cervical ripening in termination of pregnancy between 8 and 12 weeks: a randomized controlled trial. Archives of Gynecology and Obstetrics 2011;283(6):1245‐8.

Referencias adicionales

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estudios incluidos
estudios excluidos

Allen RH, Goldberg AB, Board of Society of Family Planning. Cervical dilation before first‐trimester surgical abortion (<14 weeks' gestation). SFP Guideline 20071. Contraception 2007;76(2):139‐56.

Ekerhovd E, Radulovic N, Norström A. Gemeprost versus misoprostol for cervical priming before first‐trimester abortion: a randomized controlled trial. Obstetrics and Gynecology 2003;101(4):722‐5.

Grimes DA, Schulz KF, Cates WJ. Prevention of uterine perforation during curettage abortion. JAMA 1984;251(16):2108‐11.

Hakim‐Elahi E, Tovell HM, Burnhill MS. Complications of first‐trimester abortion: a report of 170,000 cases. Obstetrics and Gynecology 1990;76(1):129‐35.

Hayashi RH. Spontaneous and induced cervical ripening. Natural dilation and effacement process and current cervical ripening techniques. Journal of Reproductive Medicine 1993;38(1 Suppl):66‐72.

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Ledingham MA, Thomson AJ, Young A, Macara LM, Greer IA, Norman JE. Changes in the expression of nitric oxide synthase in the human uterine cervix during pregnancy and parturition. Molecular Human Reproduction 2000;6(11):1041‐8.

Royal College of Obstetricians and Gynaecologists. The care of women requesting induced abortion. Evidence‐based guideline No.7. London: RCOG Press, 2011.

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.

Schulz KF, Grimes DA, Cates W. Measures to prevent cervical injury during suction curettage abortion. The Lancet 1983;1(8335):1182‐5.

Sharma S, Refaey H, Stafford M, Purkayastha S, Parry M, Axby H. Oral versus vaginal misoprostol administered one hour before surgical termination of pregnancy: a randomised controlled trial. BJOG: An International Journal of Obstetrics and Gynaecology 2005;112(4):456‐60.

Tschugguel W, Schneeberger C, Lass H, Stonek F, Zaghlula MB, Czerwenka K, et al. Human cervical ripening is associated with an increase in cervical inducible nitric oxide synthase expression. Biology of Reproduction 1999;60(6):1367‐72.

World Health Organization. Safe abortion: technical and policy guidance for health systems. http://apps.who.int/iris/bitstream/10665/70914/1/9789241548434_eng.pdf (accessed 16 October 2014).

Zhou W, Nielsen GL, Møller M, Olsen J. Short‐term complications after surgically induced abortions: a register‐based study of 56 117 abortions. Acta Obstetricia et Gynecologica Scandinavica 2002;81(4):331‐6.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

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estudios excluidos

Arteaga‐Troncoso 2005

Methods	Randomisation: computer‐generated randomisation Allocation concealment: sequentially numbered microvial in sealed, opaque envelopes prepared by the pharmacist Blinding: Participants, caregivers, and outcome assessors were blinded to the treatment given. Follow‐up: no loss of participants reported
Participants	60 women, 30 in each group Inclusion: first trimester of pregnancy, no evidence of cervical change, no history of hypotension, and ultrasound evidence of a gestational sac and a nonviable embryo Exclusion: no information provided
Interventions	Endocervical Group 1: isosorbide dinitrate 80 mg/1.5 ml gel solution Group 2: misoprostol 400 μg/1.5 ml gel solution Every 3 hours until reaching cervical dilation > 8 mm (maximum 4 doses)
Outcomes	Probability of reaching cervical dilation > 8 mm at 3, 6, 9, 12 hours Side effects
Notes	3 cases in misoprostol group required hospital admission due to pain.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ adequate

Chan 2005

Methods	Randomisation: randomisation table, nulliparous and multiparous women were randomised separately Allocation concealment: sequentially numbered and sealed, opaque envelopes prepared by the research nurse Blinding: Participants and outcome assessors (the surgeons) were blinded to the treatment given. Follow‐up: no loss of participants reported
Participants	200 women (100 nulliparous and 100 multiparous), 100 in each group Inclusion: primipara or multipara admitted for abortion at 8 to 12 weeks by suction evacuation Exclusion: previous uterine operation, allergy to sodium nitroprusside or misoprostol, chronic disease requiring medication, unable to understand the consent form, and age < 18 years
Interventions	Group 1: vaginal misoprostol 400 μg and intracervical placebo gel Group 2: intracervical sodium nitroprusside gel 10 mg and vaginal vitamin B₆ tablets 3 hours before the procedure
Outcomes	Cumulative force required to dilate cervix from 4 mm to 9 mm Baseline cervical dilation Changes in blood pressure Duration of operation Operative blood loss Side effects
Notes	The investigator who performed the operation supervised the nurse administering the drug.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ adequate

Facchinetti 2000

Methods	Randomisation: computer‐generated randomisation Allocation concealment: Preparations of placebo and active gel were similar in syringes, consistency, and volume, but active gel was brown and placebo gel was white. Blinding: Participants and outcome assessor (the surgeon) were blinded to the treatment given. Follow‐up: 3 subjects (1 in the placebo and 2 in the nitroprusside group) dropped out of the study.
Participants	36 women, 18 in each group Inclusion: first pregnancy, pregnancy dating between 9 and 12.5 weeks determined by last menstrual period and clinical examination, filling requirement of Italian Law number 194/78, and undergoing uterine evacuation under local anesthesia Exclusion: inability to understand the consent form, multiple pregnancy, previous uterine surgery, known allergy to drugs, and any chronic disease requiring medication
Interventions	First series (18 women): intracervical Group 1: placebo Group 2: 1% nitroprusside gel (5 mg) Followed by uterine evacuation 6 hours after treatment Second series (18 women): intracervical Group 1: placebo Group 2: 2% nitroprusside gel (10 mg) Followed by uterine evacuation 3 hours after treatment
Outcomes	Cumulative force required to dilate cervix from 4 mm to 8 mm Blood pressure change
Notes	The calculated sample size to reach statistical significance was 36.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ unclear

Ledingham 2001

Methods	Randomisation: random number table Allocation concealment: sequentially numbered sealed, opaque envelopes Blinding: Participants and surgeons were blinded to the treatment given; the investigator who allocated the treatment assessed the side effects of the drugs. Follow‐up: 1 woman in misoprostol group withdrew after randomisation.
Participants	66 women, 22 in each group Inclusion: primigravid women undergoing surgical termination by vacuum extraction before 12 weeks of gestation Exclusion: previous cervical surgery, threatened miscarriage
Interventions	Intravaginal Group 1: isosorbide mononitrate 40 mg Group 2: misoprostol 400 μg Group 3: isosorbide mononitrate 40 mg and misoprostol 400 μg 3 hours before surgery
Outcomes	Cumulative force required to dilate cervix to 8 mm Intraoperative blood loss Side effects
Notes	The investigator who allocated the treatment administered the symptom questionnaires (the questions were read from a script and the women were asked to respond "Yes" or "No" to the questions).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ adequate

Li 2003

Methods	Randomisation: computer‐generated randomisation; nulliparous and multiparous women were randomised separately Allocation concealment: sequentially numbered, sealed, opaque envelopes by the research nurse Blinding: Participants and outcome assessors (the surgeons) were blinded to the treatment given. Follow‐up: no loss of participants reported
Participants	126 women (63 nulliparous and 63 multiparous), 42 in each group Inclusion: healthy women requesting termination of pregnancy between 9 and 12 weeks gestation Exclusion: no information provided
Interventions	Intravaginal moistened drugs 4 to 6 hours before suction evacuation Group 1: placebo Group 2: isosorbide mononitrate 40 mg Group 3: misoprostol 400 μg
Outcomes	Baseline cervical dilatation Cumulative force for cervical dilation up to 8 mm Side effects Patient satisfaction
Notes	Significantly more smokers in the misoprostol group The author did not state the characteristics of placebo.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ adequate

Phusaanantakul 2010

Methods	Randomisation: computer‐generated randomisation Allocation concealment: sequentially numbered, sealed, opaque envelopes Blinding: Participants, caregivers, and outcome assessors were blinded to the treatment given. Follow‐up: no loss of participants reported
Participants	48 women, 24 in each group Inclusion criteria: nonviable fetus of less than 12 weeks of gestation, undergoing suction evacuation under general anesthesia, and no history of hypotension Exclusion criteria: previous cervical surgery, inevitable abortion, incomplete abortion, underlying medical diseases, allergy to isosorbide mononitrate, and unwilling to participate
Interventions	Intravaginal Group I: isosorbide mononitrate 20 mg Group II: placebo 4 hours before suction evacuation
Outcomes	Cervical width prior to suction evacuation Duration of operation Complications of the procedure Patient satisfaction Adverse effects of the drugs
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ adequate

Radulovic 2007

Methods	Randomisation: method of generation of the random allocation sequence: unclear Allocation concealment: sequentially numbered, sealed, opaque envelopes, separate numbering for assessment of cervical ripening and side effects and assessment of side effects only Blinding: Participants and outcome assessors (the surgeons) were blinded to the treatment given. Follow‐up: 28 women dropped out (16 in the group included for assessment of cervical ripening and side effects, 12 in the group included for assessment of side effects only)
Participants	148 women scheduled for surgical termination of pregnancy 76 for assessment of cervical ripening and side effects, 72 for assessment of side effects only Inclusion: healthy women with a viable singleton pregnancy and gestational age less than 12 weeks, assessed by transvaginal ultrasonography Exclusion: previous cervical surgery, ongoing vaginal bleeding, uterine‐related pain, and known allergy to either isosorbide mononitrate or misoprostol
Interventions	The women self‐administered intravaginally Group 1: isosorbide mononitrate 40 mg Group 2: misoprostol 200 μg 9 to 13 hours before surgery
Outcomes	Baseline cervical dilatation Cumulative force to dilate the cervix to 9 mm Side effects
Notes	The calculated sample size to reach statistical significance was 30 in each group for cervical ripening and 58 in each group for side effects.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ adequate

Thomson 1997

Methods	Randomisation: random‐number table Allocation concealment: sequentially numbered, sealed, opaque envelopes Blinding: Participants and outcome assessor (the surgeon) were blinded to the treatment given. Follow‐up: no loss of participants reported
Participants	48 women, 12 in each group Inclusion: primigravid women referred for surgical termination of pregnancy by vacuum aspiration before 12 weeks of gestation Exclusion: no information provided
Interventions	Intravaginal Group 1: isosorbide mononitrate 40 mg Group 2: glyceryl trinitrate 500 μg Group 3: gemeprost 1 mg Group 4: no treatment (vaginal examination only) 3 hours before surgery
Outcomes	Cumulative force to dilate the cervix to 8 mm Cervical diameter before surgical dilatation
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	A ‐ adequate

Thomson 1998

Methods	Randomisation: random‐number table Allocation concealment: sequentially numbered, sealed, opaque envelopes Blinding: The investigator who allocated the treatment administered the symptom questionnaires; participants and surgeons were blinded to the treatment given. Follow‐up: no loss of participants reported
Participants	66 women, 22 in each group Inclusion: primigravid women scheduled for vacuum aspiration in the first trimester Exclusion: any previous pregnancy, previous cervical surgery, signs of threatened miscarriage, or concurrent maternal disease
Interventions	Intravaginal Group 1: gemeprost 1 mg Group 2: isosorbide mononitrate 40 mg Group 3: isosorbide mononitrate 80 mg 3 hours before surgery
Outcomes	Onset of new symptoms before abortion Cervical diameter before surgical dilatation Cumulative force to dilate the cervix to 8 mm
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Unclear risk	B ‐ unclear

Characteristics of excluded studies [ordered by study ID]

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estudios incluidos

Study	Reason for exclusion
Chen 2008	No information about randomisation, allocation concealment, or blinding provided. Number of participants described in the article's results section was different from number cited in the table. We could not contact the author.
David 2003	Brief communication. No information about randomisation, allocation concealment, or blinding provided. The results were published without details of the outcomes. We could not contact the author.
David 2005	No information about randomisation, allocation concealment, or blinding provided. Incomplete data in the published results. We could not contact the author.
Duhan 2011	No information about randomisation, allocation concealment, or blinding provided. We could not contact the author.

Data and analyses

Open in table viewer

Comparison 1. Nitric oxide donors versus placebo or no treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Baseline cervical dilatation before the procedure Show forest plot	3	168	Mean Difference (IV, Fixed, 95% CI)	0.30 [0.01, 0.58]
Open in figure viewer Analysis 1.1 Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 1 Baseline cervical dilatation before the procedure.
2 Cumulative force required to dilate cervix to 8 mm Show forest plot	3	153	Mean Difference (IV, Fixed, 95% CI)	‐4.29 [‐9.92, 1.35]
Open in figure viewer Analysis 1.2 Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 2 Cumulative force required to dilate cervix to 8 mm.
3 Side effects: Headache Show forest plot	3	165	Risk Ratio (M‐H, Fixed, 95% CI)	1.73 [0.86, 3.46]
Open in figure viewer Analysis 1.3 Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 3 Side effects: Headache.
4 Side effect: Abdominal pain Show forest plot	2	117	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.50, 1.50]
Open in figure viewer Analysis 1.4 Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 4 Side effect: Abdominal pain.
5 Side effect: Nausea/vomiting Show forest plot	3	165	Risk Ratio (M‐H, Fixed, 95% CI)	2.62 [1.07, 6.45]
Open in figure viewer Analysis 1.5 Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 5 Side effect: Nausea/vomiting.
6 Patient satisfaction Show forest plot	1	84	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.84, 1.07]
Open in figure viewer Analysis 1.6 Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 6 Patient satisfaction.

Open in table viewer

Comparison 2. Nitric oxide donors versus prostaglandins

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Cumulative force required to dilate cervix to 8‐9 mm Show forest plot	5	429	Mean Difference (IV, Fixed, 95% CI)	13.12 [9.72, 16.52]
Open in figure viewer Analysis 2.1 Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 1 Cumulative force required to dilate cervix to 8‐9 mm.
2 Baseline cervical dilatation before the procedure Show forest plot	4	386	Mean Difference (IV, Fixed, 95% CI)	‐0.73 [‐1.01, ‐0.45]
Open in figure viewer Analysis 2.2 Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 2 Baseline cervical dilatation before the procedure.
3 Probability of reaching cervical ripening > 8 mm at 3 hours Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	6.67 [2.21, 20.09]
Open in figure viewer Analysis 2.3 Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 3 Probability of reaching cervical ripening > 8 mm at 3 hours.
4 Side effect: Headache Show forest plot	5	507	Risk Ratio (M‐H, Fixed, 95% CI)	5.13 [3.29, 8.00]
Open in figure viewer Analysis 2.4 Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 4 Side effect: Headache.
5 Side effect: Palpitation Show forest plot	4	447	Risk Ratio (M‐H, Fixed, 95% CI)	3.43 [1.64, 7.15]
Open in figure viewer Analysis 2.5 Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 5 Side effect: Palpitation.
6 Side effect: Dizziness Show forest plot	3	327	Risk Ratio (M‐H, Fixed, 95% CI)	3.29 [1.46, 7.41]
Open in figure viewer Analysis 2.6 Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 6 Side effect: Dizziness.
7 Side effect: Abdominal pain Show forest plot	5	507	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.25, 0.44]
Open in figure viewer Analysis 2.7 Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 7 Side effect: Abdominal pain.
8 Side effect: Vaginal bleeding Show forest plot	4	447	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.07, 0.27]
Open in figure viewer Analysis 2.8 Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 8 Side effect: Vaginal bleeding.
9 Side effect: Nausea/Vomiting Show forest plot	5	507	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.94, 1.46]
Open in figure viewer Analysis 2.9 Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 9 Side effect: Nausea/Vomiting.
10 Patient satisfaction Show forest plot	1	84	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.92, 1.28]
Open in figure viewer Analysis 2.10 Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 10 Patient satisfaction.
11 Intraoperative blood loss Show forest plot	4	393	Mean Difference (IV, Fixed, 95% CI)	33.59 [24.50, 42.67]
Open in figure viewer Analysis 2.11 Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 11 Intraoperative blood loss.

Open in table viewer

Comparison 3. Nitric oxide donor versus nitric oxide donor and prostaglandin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Cumulative force required to dilate cervix to 8 mm Show forest plot	1	44	Mean Difference (IV, Fixed, 95% CI)	14.5 [0.50, 28.50]
Open in figure viewer Analysis 3.1 Comparison 3 Nitric oxide donor versus nitric oxide donor and prostaglandin, Outcome 1 Cumulative force required to dilate cervix to 8 mm.
2 Side effect: Headache Show forest plot	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.38, 2.00]
Open in figure viewer Analysis 3.2 Comparison 3 Nitric oxide donor versus nitric oxide donor and prostaglandin, Outcome 2 Side effect: Headache.
3 Side effect: Abdominal pain Show forest plot	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.02, 1.07]
Open in figure viewer Analysis 3.3 Comparison 3 Nitric oxide donor versus nitric oxide donor and prostaglandin, Outcome 3 Side effect: Abdominal pain.
4 Intraoperative blood loss Show forest plot	1	44	Mean Difference (IV, Fixed, 95% CI)	‐50.0 [‐164.19, 64.19]
Open in figure viewer Analysis 3.4 Comparison 3 Nitric oxide donor versus nitric oxide donor and prostaglandin, Outcome 4 Intraoperative blood loss.

Figure 1

Forest plot of comparison: 1 Nitric oxide donors versus placebo or no treatment, outcome: 1.1 Baseline cervical dilatation before the procedure.

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Figure 2

Forest plot of comparison: 1 Nitric oxide donors versus placebo or no treatment, outcome: 1.2 Cumulative force required to dilate cervix to 8 mm.

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Figure 3

Forest plot of comparison: 1 Nitric oxide donors versus placebo or no treatment, outcome: 1.3 Side effect: Headache.

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Figure 4

Forest plot of comparison: 1 Nitric oxide donors versus placebo or no treatment, outcome: 1.4 Side effect: Abdominal pain.

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Figure 5

Forest plot of comparison: 1 Nitric oxide donors versus placebo or no treatment, outcome: 1.6 Patient satisfaction.

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Figure 6

Forest plot of comparison: 1 Nitric oxide donors versus placebo or no treatment, outcome: 1.5 Side effect: Nausea/vomiting.

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Figure 7

Forest plot of comparison: 2 Nitric oxide donors versus prostaglandins, outcome: 2.1 Cumulative force required to dilate cervix to 8‐9 mm.

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Figure 8

Forest plot of comparison: 2 Nitric oxide donors versus prostaglandins, outcome: 2.2 Baseline cervical dilatation before the procedure.

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Figure 9

Forest plot of comparison: 2 Nitric oxide donors versus prostaglandins, outcome: 2.11 Probability of reaching cervical ripening > 8 mm at 3 hours.

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Figure 10

Forest plot of comparison: 2 Nitric oxide donors versus prostaglandins, outcome: 2.3 Side effect: Headache.

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Figure 11

Forest plot of comparison: 2 Nitric oxide donors versus prostaglandins, outcome: 2.6 Side effect: Palpitation.

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Figure 12

Forest plot of comparison: 2 Nitric oxide donors versus prostaglandins, outcome: 2.7 Side effect: Dizziness.

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Figure 13

Forest plot of comparison: 2 Nitric oxide donors versus prostaglandins, outcome: 2.4 Side effect: Abdominal pain.

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Figure 14

Forest plot of comparison: 2 Nitric oxide donors versus prostaglandins, outcome: 2.5 Side effect: Vaginal bleeding.

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Figure 15

Forest plot of comparison: 2 Nitric oxide donors versus prostaglandins, outcome: 2.8 Side effect: Nausea/Vomiting.

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Figure 16

Forest plot of comparison: 2 Nitric oxide donors versus prostaglandins, outcome: 2.10 Patient satisfaction.

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Figure 17

Forest plot of comparison: 2 Nitric oxide donors versus prostaglandins, outcome: 2.9 Intraoperative blood loss.

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Figure 18

Forest plot of comparison: 3 Nitric oxide donor versus nitric oxide donor and prostaglandin, outcome: 3.1 Cumulative force required to dilate cervix to 8 mm.

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Figure 19

Forest plot of comparison: 3 Nitric oxide donor versus nitric oxide donor and prostaglandin, outcome: 3.2 Side effect: Headache.

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Figure 20

Forest plot of comparison: 3 Nitric oxide donor versus nitric oxide donor and prostaglandin, outcome: 3.3 Side effect: Abdominal pain.

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Figure 21

Forest plot of comparison: 3 Nitric oxide donor versus nitric oxide donor and prostaglandin, outcome: 3.4 Intraoperative blood loss.

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Analysis 1.1

Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 1 Baseline cervical dilatation before the procedure.

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Analysis 1.2

Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 2 Cumulative force required to dilate cervix to 8 mm.

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Analysis 1.3

Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 3 Side effects: Headache.

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Analysis 1.4

Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 4 Side effect: Abdominal pain.

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Analysis 1.5

Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 5 Side effect: Nausea/vomiting.

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Analysis 1.6

Comparison 1 Nitric oxide donors versus placebo or no treatment, Outcome 6 Patient satisfaction.

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Analysis 2.1

Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 1 Cumulative force required to dilate cervix to 8‐9 mm.

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Analysis 2.2

Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 2 Baseline cervical dilatation before the procedure.

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Analysis 2.3

Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 3 Probability of reaching cervical ripening > 8 mm at 3 hours.

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Analysis 2.4

Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 4 Side effect: Headache.

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Analysis 2.5

Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 5 Side effect: Palpitation.

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Analysis 2.6

Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 6 Side effect: Dizziness.

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Analysis 2.7

Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 7 Side effect: Abdominal pain.

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Analysis 2.8

Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 8 Side effect: Vaginal bleeding.

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Analysis 2.9

Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 9 Side effect: Nausea/Vomiting.

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Analysis 2.10

Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 10 Patient satisfaction.

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Analysis 2.11

Comparison 2 Nitric oxide donors versus prostaglandins, Outcome 11 Intraoperative blood loss.

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Analysis 3.1

Comparison 3 Nitric oxide donor versus nitric oxide donor and prostaglandin, Outcome 1 Cumulative force required to dilate cervix to 8 mm.

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Analysis 3.2

Comparison 3 Nitric oxide donor versus nitric oxide donor and prostaglandin, Outcome 2 Side effect: Headache.

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Analysis 3.3

Comparison 3 Nitric oxide donor versus nitric oxide donor and prostaglandin, Outcome 3 Side effect: Abdominal pain.

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Analysis 3.4

Comparison 3 Nitric oxide donor versus nitric oxide donor and prostaglandin, Outcome 4 Intraoperative blood loss.

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Comparison 1. Nitric oxide donors versus placebo or no treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Baseline cervical dilatation before the procedure Show forest plot	3	168	Mean Difference (IV, Fixed, 95% CI)	0.30 [0.01, 0.58]

2 Cumulative force required to dilate cervix to 8 mm Show forest plot	3	153	Mean Difference (IV, Fixed, 95% CI)	‐4.29 [‐9.92, 1.35]

3 Side effects: Headache Show forest plot	3	165	Risk Ratio (M‐H, Fixed, 95% CI)	1.73 [0.86, 3.46]

4 Side effect: Abdominal pain Show forest plot	2	117	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.50, 1.50]

5 Side effect: Nausea/vomiting Show forest plot	3	165	Risk Ratio (M‐H, Fixed, 95% CI)	2.62 [1.07, 6.45]

6 Patient satisfaction Show forest plot	1	84	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.84, 1.07]

Comparison 1. Nitric oxide donors versus placebo or no treatment

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Comparison 2. Nitric oxide donors versus prostaglandins

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Cumulative force required to dilate cervix to 8‐9 mm Show forest plot	5	429	Mean Difference (IV, Fixed, 95% CI)	13.12 [9.72, 16.52]

2 Baseline cervical dilatation before the procedure Show forest plot	4	386	Mean Difference (IV, Fixed, 95% CI)	‐0.73 [‐1.01, ‐0.45]

3 Probability of reaching cervical ripening > 8 mm at 3 hours Show forest plot	1	60	Risk Ratio (M‐H, Fixed, 95% CI)	6.67 [2.21, 20.09]

4 Side effect: Headache Show forest plot	5	507	Risk Ratio (M‐H, Fixed, 95% CI)	5.13 [3.29, 8.00]

5 Side effect: Palpitation Show forest plot	4	447	Risk Ratio (M‐H, Fixed, 95% CI)	3.43 [1.64, 7.15]

6 Side effect: Dizziness Show forest plot	3	327	Risk Ratio (M‐H, Fixed, 95% CI)	3.29 [1.46, 7.41]

7 Side effect: Abdominal pain Show forest plot	5	507	Risk Ratio (M‐H, Fixed, 95% CI)	0.33 [0.25, 0.44]

8 Side effect: Vaginal bleeding Show forest plot	4	447	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.07, 0.27]

9 Side effect: Nausea/Vomiting Show forest plot	5	507	Risk Ratio (M‐H, Fixed, 95% CI)	1.17 [0.94, 1.46]

10 Patient satisfaction Show forest plot	1	84	Risk Ratio (M‐H, Fixed, 95% CI)	1.09 [0.92, 1.28]

11 Intraoperative blood loss Show forest plot	4	393	Mean Difference (IV, Fixed, 95% CI)	33.59 [24.50, 42.67]

Comparison 2. Nitric oxide donors versus prostaglandins

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Comparison 3. Nitric oxide donor versus nitric oxide donor and prostaglandin

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Cumulative force required to dilate cervix to 8 mm Show forest plot	1	44	Mean Difference (IV, Fixed, 95% CI)	14.5 [0.50, 28.50]

2 Side effect: Headache Show forest plot	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.88 [0.38, 2.00]

3 Side effect: Abdominal pain Show forest plot	1	44	Risk Ratio (M‐H, Fixed, 95% CI)	0.14 [0.02, 1.07]

4 Intraoperative blood loss Show forest plot	1	44	Mean Difference (IV, Fixed, 95% CI)	‐50.0 [‐164.19, 64.19]

Comparison 3. Nitric oxide donor versus nitric oxide donor and prostaglandin

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Referencias

Referencias de los estudios incluidos en esta revisión

Arteaga‐Troncoso 2005 {published data only}

Chan 2005 {published data only}

Facchinetti 2000 {published data only}

Ledingham 2001 {published data only}

Li 2003 {published data only}

Phusaanantakul 2010 {published data only (unpublished sought but not used)}

Radulovic 2007 {published data only}

Thomson 1997 {published data only}

Thomson 1998 {published data only}

Referencias de los estudios excluidos de esta revisión

Chen 2008 {published data only}

David 2003 {published data only}

David 2005 {published data only}

Duhan 2011 {published data only}

Referencias adicionales

Allen 2007

Ekerhovd 2003

Grimes 1984

Hakim‐Elahi 1990

Hayashi 1993

Higgins 2011

Ledingham 2000

RCOG 2011

RevMan 5 [Computer program]

Schulz 1983

Sharma 2005

Tschugguel 1999

WHO 2012

Zhou 2002

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Data and analyses

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Instituciones a las que se accedió previamente

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