Outcome of Vaginal Progesterone as a Tocolytic Agent: Randomized Clinical Trial

Gargari, Soraya Saleh; Habibolahi, Malihe; Zonobi, Zahra; Khani, Zahra; Sarfjoo, Fatemeh Sadat; Robati, Atefeh Kazemi; Etemad, Roja; Karimi, Zohreh

doi:10.5402/2012/607906

Cited by 16 publications

(28 citation statements)

References 39 publications

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“…The details of the included trials are presented in Table 1 . Two trials employed oral progesterone [ 12 , 13 ], three used intra-muscular 17-hydroxyprogesterone caporate [ 14 – 16 ], our trial and seven others used vaginal progesterone [ 17 – 23 ] and one trial compared intramuscular 17-hydroxyprogesterone caporate or vaginal progesterone to no treatment [ 24 ]. Eight authors were contacted by email requesting additional information regarding outcomes not reported in their manuscripts and responses were received from three.…”

Section: Resultsmentioning

confidence: 99%

“… Progesterone 200 mg vaginally/Placebo. Briery [ 16 ] 2014 USA 45 20–30 weeks gestation, tocolysis with NSAIDS, nifedipine or MgSO4 17-hydroxyprogesterone caporate 250 mg IM weekly/ Placebo Gargari [ 23 ] 2012 Iran 110 24–33 weeks gestation, tocolysis with MgSO4 Progesterone 400 mg vaginally/No treatment Wood 2017 Canada 41 23–33 weeks gestation, after tocolysis with NSAIDS or nifedipine or no tocolysis and positive vaginal fetal fibronectin Progesterone 200 mg vaginally/Placebo. …”

Section: Resultsmentioning

confidence: 99%

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Progesterone in women with arrested premature labor, a report of a randomised clinical trial and updated meta-analysis

Wood

Rabi

Tang

et al. 2017

BMC Pregnancy Childbirth

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Background: Progesterone may be effective in prevention of premature birth in some high risk populations. Women with arrested premature labor are at risk of recurrent labor and maintenance therapy with standard tocolytics has not been successful. Methods: Randomized double blinded clinical trial of daily treatment with 200 mg vaginal progesterone in women with arrested premature labor and an updated meta-analysis. Results: The clinical trial was terminated early after 41 women were enrolled. Vaginal progesterone treatment did not change the median gestational age at delivery: 36+2 weeks versus 36+4 weeks, p = .865 nor increase the mean latency to delivery: 44.5 days versus 46.6 days, p = .841. In the updated meta-analysis, progesterone treatment did reduce delivery <37 weeks gestation and increase latency to delivery, but this treatment effect was not evident in the high quality trials: (OR 1.23, 95% CI 0.91, 1.67) and (−0.95 days, 95% CI −5.54, 3.64) respectively. Conclusion: Progesterone is not effective for preventing preterm birth following arrested preterm labor.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Progesterone in women with arrested premature labor, a report of a randomised clinical trial and updated meta-analysis

Wood

Rabi

Tang

et al. 2017

BMC Pregnancy Childbirth

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“…Yet since no study directly compared the efficacy of 100 and 200 mg, there is no explicit evidence on which dosage has greater effect in preventing PTB. Vaginal progesterone suppository was dosed either 200 or 400 mg when used in twin pregnancies [ 28 29 30 31 ] or as a treatment after inhibition of preterm labor [ 32 33 34 35 36 ], but the optimal dose and its efficacy in twin pregnancies and preterm labor requires further evidence.…”

Section: Type Routes Dose and Interval Of Administrationmentioning

confidence: 99%

Use of progesterone supplement therapy for prevention of preterm birth: review of literatures

Choi

2017

Obstet Gynecol Sci

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Preterm birth (PTB) is one of the most common complications during pregnancy and it primarily accounts for neonatal mortality and numerous morbidities including long-term sequelae including cerebral palsy and developmental disability. The most effective treatment of PTB is prediction and prevention of its risks. Risk factors of PTB include history of PTB, short cervical length (CL), multiple pregnancies, ethnicity, smoking, uterine anomaly and history of curettage or cervical conization. Among these risk factors, history of PTB, and short CL are the most important predictive factors. Progesterone supplement therapy is one of the few proven effective methods to prevent PTB in women with history of spontaneous PTB and in women with short CL. There are 2 types of progesterone therapy currently used for prevention of PTB: weekly intramuscular injection of 17-alpha hydroxyprogesterone caproate and daily administration of natural micronized progesterone vaginal gel, vaginal suppository, or oral capsule. However, the efficacy of progesterone therapy to prevent PTB may vary depending on the administration route, form, dose of progesterone and indications for the treatment. This review aims to summarize the efficacy and safety of progesterone supplement therapy on prevention of PTB according to different indication, type, route, and dose of progesterone, based on the results of recent randomized trials and meta-analysis.

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“…In various studies improvement in birth weight ranged from 290-490 gms. 11,[13][14][15]18 NICU admission were also less in study group(14% vs 24%) with shorter nursery stay(7.71 vs 8.41 days).Neonatal complications like RDS, sepsis, mechanical ventilation were also less in study group. There was one case of neonatal death in Group II.…”

Section: Discussionmentioning

confidence: 72%

“…Results are similar as reported in literature though progesterone, dose and route are different in various studies. 11,[13][14][15][16] Borna et al reported difference in prolongation of pregnancy by 11.5 days while Gargari et al reported it to be 2.6 weeks. Bomba-Opon et al observed a significant reduction in delivery before 34 weeks with vaginal progesterone (9.8% in progesterone group versus 35.3% in control group; p = 0.002).…”

Section: Discussionmentioning

confidence: 99%

The role of micronized progesterone in preterm labour

2020

IJOGR

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Objective: To study the role of intravaginal micronized progesterone in preterm labour in prolonging the pregnancy up to term and thus improving neonatal outcome Materials and Methods: A prospective randomized study wherein 100 pregnant women between 26-34 weeks of pregnancy admitted to labour ward with s/s of preterm labour were included in the study. After initial management with tocolytics and antenatal steroids, when the labour got arrested these women were randomly divided into two groups 1and 2. Group 1 received 200 ug of intravaginal micronized progesterone from inclusion in the study to 36 weeks or till delivery whichever was earlier.Group 2 received only supportive therapy. None of women received oral tocolytics after initial arrest of labour. All women were followed up till delivery and obstetric outcome noted Primary variables were prolongation of pregnancy from inclusion in study to delivery interval, gestation age at delivery. Neonatal outcome variables were birth weight, need for NICU transfer, length of stay in NICU and neonatal complications The results observed were subjected to statistical analysis by SPSS-13 unpaired student t-test, Mann-Whitney for quantitative variables and Chi-square/fisher exact for qualitative variables Results: The two groups were comparable in term of age, parity and rural/urban status. Baseline presentation characteristics of the two groups such as period of gestation, number of uterine contractions per 10 minutes, cervical dilatation and, cervical effacement were also comparable (p value <0.05). Mean gestational age at delivery in group 1 was significantly more than group 2 (36.808 weeks vs. 34.078 weeks). Patient delivering beyond 37 weeks of gestation were significantly more in group 1 (60%vs 14%). Prolongation of pregnancy was significantly more in group 1, mean no. of days being 34±15.25 and 24.22±12.73 in group 1 & 2 respectively. Neonatal outcome in terms of birth weight was significantly better in group 1.mean birth weight being 2675.2±382.20 and 2393.2±378.05 in group1 and 2 respectively. Neonatal complications in terms of need for NICU admission, RDS, sepsis and mechanical ventilation were more in group 2. Conclusion: In preterm labour once the labour is arrested with tocolytics, intravaginal micronized progesterone therapy is effective in prolonging the pregnancy and thus increasing the gestational age at delivery. Neonatal outcome is improved because of increased birth weight and lesser complications.

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Outcome of Vaginal Progesterone as a Tocolytic Agent: Randomized Clinical Trial

Cited by 16 publications

References 39 publications

Progesterone in women with arrested premature labor, a report of a randomised clinical trial and updated meta-analysis

Progesterone in women with arrested premature labor, a report of a randomised clinical trial and updated meta-analysis

Use of progesterone supplement therapy for prevention of preterm birth: review of literatures

The role of micronized progesterone in preterm labour

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