Maintenance Therapy by Vaginal Progesterone after Threatened Idiopathic Preterm Labor: A Randomized Placebo-Controlled Double-blind Trial
Background Patients with arrested preterm labor (PTL) are at increased risk for recurrence of preterm birth (PTB). Maintenance tocolysis after arrest of acute PTL is of questionable value. The objective of this study was to evaluate the efficacy of 200 mg vaginal progesterone in order to prevent PTB...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Royan Institute (ACECR), Tehran
2010-07-01
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| Series: | International Journal of Fertility and Sterility |
| Subjects: | |
| Online Access: | http://www.ijfs.ir/article_45822_342a01526af0f1948b3224cc243f836f.pdf |
| _version_ | 1818532228786814976 |
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| author | Seyede Hajar Sharami Ziba Zahiri Maryam Shakiba Frozan Milani |
| author_facet | Seyede Hajar Sharami Ziba Zahiri Maryam Shakiba Frozan Milani |
| author_sort | Seyede Hajar Sharami |
| collection | DOAJ |
| description | Background
Patients with arrested preterm labor (PTL) are at increased risk for recurrence of preterm birth (PTB). Maintenance tocolysis after arrest of acute PTL is of questionable value. The objective of this study was to evaluate the efficacy of 200 mg vaginal progesterone in order to prevent PTB in women with episodes of threatened PTL.
Materials and methods
This is a randomized double blind clinical trial study.Women with singleton pregnancies between 28-36 weeks of gestation, who were hospitalized for PTL were included. A total of 173 pregnant patients were randomly allocated to receive 200 mg vaginal progesterone suppositories (n=86) or placebo (n=87) daily until the 36th gestational week. The two groups were compared relative to demographic characteristics, incidence of PTB before 34 and 37 weeks, and maternal and neonatal complications. Data were analyzed by chi-square and Fisher’s exact tests.
Results
Mean latency until delivery in the cases was longer than the control group (23.88 ± 18.01 vs. 16.67 ± 12.9; p=0.004).Treatment with progesterone was not associated with a reduction in the rate of PTB before 34 weeks [cases: 9 (10.8%) vs. controls: 8 (10%)] and 37 weeks [cases: 45 (54.2%) vs. controls: 33 (41.2%)]. Log rank analysis revealed a significant difference for mean time to delivery between the two groups (p=0.028). There were no significant differences for neonatal and maternal complications in the two groups.
Conclusion
Prophylactic administration of 200 mg vaginal progesterone suppositories after successful tocolysis in patients with threatened idiopathic PTL is associated with a longer latency to delivery, but failed to reduce the rate of PTB (Registeration Number: IRCT138706051096N1). |
| first_indexed | 2024-12-11T17:42:46Z |
| format | Article |
| id | doaj.art-4341bdc496e54ae489ccd5562caf17fb |
| institution | Directory Open Access Journal |
| issn | 2008-076X 2008-0778 |
| language | English |
| last_indexed | 2024-12-11T17:42:46Z |
| publishDate | 2010-07-01 |
| publisher | Royan Institute (ACECR), Tehran |
| record_format | Article |
| series | International Journal of Fertility and Sterility |
| spelling | doaj.art-4341bdc496e54ae489ccd5562caf17fb2022-12-22T00:56:28ZengRoyan Institute (ACECR), TehranInternational Journal of Fertility and Sterility2008-076X2008-07782010-07-0142455010.22074/ijfs.2010.4582245822Maintenance Therapy by Vaginal Progesterone after Threatened Idiopathic Preterm Labor: A Randomized Placebo-Controlled Double-blind TrialSeyede Hajar Sharami0Ziba Zahiri1Maryam Shakiba2Frozan Milani3Reproductive Health Research Center, Obstetrics and Gynecology Department, Alzahra Hospital, . Reproductive Health Research Center, Obstetrics and Gynecology Department, Alzahra Hospital, Guilan University of Medical Sciences, Rasht, IranReproductive Health Research Center, Obstetrics and Gynecology Department, Alzahra Hospital, . Reproductive Health Research Center, Obstetrics and Gynecology Department, Alzahra Hospital, Guilan University of Medical Sciences, Rasht, IranResearch Vice Chancellorship, Guilan University of Medical Sciences, Rasht , Iran . Research Vice Chancellorship, Guilan University of Medical Sciences, Rasht , Iran Mehr Research Infertility Institute, Rasht, IranPerinatology Department, Alzahra Hospital, Guilan University of Medical Sciences, Rasht, IranBackground Patients with arrested preterm labor (PTL) are at increased risk for recurrence of preterm birth (PTB). Maintenance tocolysis after arrest of acute PTL is of questionable value. The objective of this study was to evaluate the efficacy of 200 mg vaginal progesterone in order to prevent PTB in women with episodes of threatened PTL. Materials and methods This is a randomized double blind clinical trial study.Women with singleton pregnancies between 28-36 weeks of gestation, who were hospitalized for PTL were included. A total of 173 pregnant patients were randomly allocated to receive 200 mg vaginal progesterone suppositories (n=86) or placebo (n=87) daily until the 36th gestational week. The two groups were compared relative to demographic characteristics, incidence of PTB before 34 and 37 weeks, and maternal and neonatal complications. Data were analyzed by chi-square and Fisher’s exact tests. Results Mean latency until delivery in the cases was longer than the control group (23.88 ± 18.01 vs. 16.67 ± 12.9; p=0.004).Treatment with progesterone was not associated with a reduction in the rate of PTB before 34 weeks [cases: 9 (10.8%) vs. controls: 8 (10%)] and 37 weeks [cases: 45 (54.2%) vs. controls: 33 (41.2%)]. Log rank analysis revealed a significant difference for mean time to delivery between the two groups (p=0.028). There were no significant differences for neonatal and maternal complications in the two groups. Conclusion Prophylactic administration of 200 mg vaginal progesterone suppositories after successful tocolysis in patients with threatened idiopathic PTL is associated with a longer latency to delivery, but failed to reduce the rate of PTB (Registeration Number: IRCT138706051096N1).http://www.ijfs.ir/article_45822_342a01526af0f1948b3224cc243f836f.pdfpreterm laborpreterm birthvaginal tabletprogesterone |
| spellingShingle | Seyede Hajar Sharami Ziba Zahiri Maryam Shakiba Frozan Milani Maintenance Therapy by Vaginal Progesterone after Threatened Idiopathic Preterm Labor: A Randomized Placebo-Controlled Double-blind Trial International Journal of Fertility and Sterility preterm labor preterm birth vaginal tablet progesterone |
| title | Maintenance Therapy by Vaginal Progesterone after Threatened Idiopathic Preterm Labor: A Randomized Placebo-Controlled Double-blind Trial |
| title_full | Maintenance Therapy by Vaginal Progesterone after Threatened Idiopathic Preterm Labor: A Randomized Placebo-Controlled Double-blind Trial |
| title_fullStr | Maintenance Therapy by Vaginal Progesterone after Threatened Idiopathic Preterm Labor: A Randomized Placebo-Controlled Double-blind Trial |
| title_full_unstemmed | Maintenance Therapy by Vaginal Progesterone after Threatened Idiopathic Preterm Labor: A Randomized Placebo-Controlled Double-blind Trial |
| title_short | Maintenance Therapy by Vaginal Progesterone after Threatened Idiopathic Preterm Labor: A Randomized Placebo-Controlled Double-blind Trial |
| title_sort | maintenance therapy by vaginal progesterone after threatened idiopathic preterm labor a randomized placebo controlled double blind trial |
| topic | preterm labor preterm birth vaginal tablet progesterone |
| url | http://www.ijfs.ir/article_45822_342a01526af0f1948b3224cc243f836f.pdf |
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