Skip to main content
Top
Published in: Archives of Gynecology and Obstetrics 1/2016

01-01-2016 | Maternal-Fetal Medicine

RETRACTED ARTICLE: Vaginal progesterone for prevention of preterm labor in asymptomatic twin pregnancies with sonographic short cervix: a randomized clinical trial of efficacy and safety

Authors: Waleed El-refaie, Mohamed S. Abdelhafez, Ahmed Badawy

Published in: Archives of Gynecology and Obstetrics | Issue 1/2016

Login to get access

Abstract

Purpose

To evaluate the value of vaginal progesterone therapy for reduction of preterm labor in asymptomatic women with twin pregnancies and sonographic short cervix.

Methods

This randomized controlled study was conducted in Mansoura University Hospital and private practice settings in Mansoura, Egypt. Of 322 women with dichorionic twin pregnancy, 250 asymptomatic women with cervical length of 20–25 mm at 20–24 weeks of gestation were included in the study. All women were randomly divided into two groups; the study group (n = 125) received vaginal progesterone suppositories in a dose of 400 mg daily starting at 20–24 weeks of gestation while the control group (n = 125) received no treatment. The primary outcome measure was preterm labor before 34 weeks of gestation and the secondary outcome measures were neonatal respiratory distress syndrome (RDS) and early neonatal death (END).

Results

224 women (116 in the study group and 108 in the control group) were subjected to final analysis. The duration of pregnancy was significantly longer in the study group and the incidence of preterm labor before 34 and 32 weeks of gestation was significantly lower in the study group. The neonatal morbidities and mortality were significantly lower in the study group as shown by lower incidence of very low (<1500 gm) birth weight, neonatal RDS, the need for mechanical ventilation and END.

Conclusions

Vaginal progesterone administration in asymptomatic twin pregnancies with sonographic short cervix (20–25 mm) at 20–24 weeks of gestation is effective and safe treatment for reducing the incidence of preterm labor with subsequent reduction in the neonatal morbidities and mortality associated with preterm birth.
Literature
1.
go back to reference Moser K, Macfarlane A, Chow YH, Hilder L, Dattani N (2007) Introducing new data on gestation-specific infant mortality among babies born in 2005 in England and Wales. Health Stat Q 35:13–27 Moser K, Macfarlane A, Chow YH, Hilder L, Dattani N (2007) Introducing new data on gestation-specific infant mortality among babies born in 2005 in England and Wales. Health Stat Q 35:13–27
2.
go back to reference Draper ES, Manktelow B, Field DJ, James D (1999) Prediction of survival for preterm births by weight and gestational age: retrospective population based study. BMJ 319(7217):1093–1097CrossRef Draper ES, Manktelow B, Field DJ, James D (1999) Prediction of survival for preterm births by weight and gestational age: retrospective population based study. BMJ 319(7217):1093–1097CrossRef
3.
go back to reference Kilpatrick SJ, Jackson R, Croughan-Minihane MS (1996) Perinatal mortality in twins and singletons matched for gestational age at delivery at ≥30 weeks. Am J Obstet Gynecol 174(1 Pt 1):66–71CrossRef Kilpatrick SJ, Jackson R, Croughan-Minihane MS (1996) Perinatal mortality in twins and singletons matched for gestational age at delivery at ≥30 weeks. Am J Obstet Gynecol 174(1 Pt 1):66–71CrossRef
4.
go back to reference Gardner MO, Goldenberg RL, Cliver SP, Tucker JM, Nelson KG, Copper RL (1995) The origin and outcome of preterm twin pregnancies. Obstet Gynecol 85(4):553–557CrossRef Gardner MO, Goldenberg RL, Cliver SP, Tucker JM, Nelson KG, Copper RL (1995) The origin and outcome of preterm twin pregnancies. Obstet Gynecol 85(4):553–557CrossRef
5.
go back to reference Hassan SS, Romero R, Berry SM, Dang K, Blackwell SC, Treadwell MC et al (2000) Patients with an ultrasonographic cervical length ≤15 mm have nearly a 50 % risk of early spontaneous preterm delivery. Am J Obstet Gynecol 182(6):1458–1467CrossRef Hassan SS, Romero R, Berry SM, Dang K, Blackwell SC, Treadwell MC et al (2000) Patients with an ultrasonographic cervical length ≤15 mm have nearly a 50 % risk of early spontaneous preterm delivery. Am J Obstet Gynecol 182(6):1458–1467CrossRef
6.
go back to reference Souka AP, Heath V, Flint S, Sevastopoulou I, Nicolaides KH (1999) Cervical length at 23 weeks in twins in predicting spontaneous preterm delivery. Obstet Gynecol 94(3):450–454PubMed Souka AP, Heath V, Flint S, Sevastopoulou I, Nicolaides KH (1999) Cervical length at 23 weeks in twins in predicting spontaneous preterm delivery. Obstet Gynecol 94(3):450–454PubMed
7.
go back to reference Guimarães Filho HA, Araujo Júnior E, Pires CR, Nardozza LM, Moron AF (2013) Short cervix syndrome: current knowledge from etiology to the control. Arch Gynecol Obstet 287(4):621–628CrossRef Guimarães Filho HA, Araujo Júnior E, Pires CR, Nardozza LM, Moron AF (2013) Short cervix syndrome: current knowledge from etiology to the control. Arch Gynecol Obstet 287(4):621–628CrossRef
8.
go back to reference O’Brien JM, Adair CD, Lewis DF, Hall DR, Defranco EA, Fusey S et al (2007) Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 30(5):687–696CrossRef O’Brien JM, Adair CD, Lewis DF, Hall DR, Defranco EA, Fusey S et al (2007) Progesterone vaginal gel for the reduction of recurrent preterm birth: primary results from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 30(5):687–696CrossRef
9.
go back to reference O’Brien JM, Defranco EA, Adair CD, Lewis DF, Hall DR, How H et al (2009) Effect of progesterone on cervical shortening in women at risk for preterm birth: secondary analysis from a multinational, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 34(6):653–659CrossRef O’Brien JM, Defranco EA, Adair CD, Lewis DF, Hall DR, How H et al (2009) Effect of progesterone on cervical shortening in women at risk for preterm birth: secondary analysis from a multinational, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 34(6):653–659CrossRef
10.
go back to reference DeFranco EA, O’Brien JM, Adair CD, Lewis DF, Hall DR, Fusey S et al (2007) Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 30(5):697–705CrossRef DeFranco EA, O’Brien JM, Adair CD, Lewis DF, Hall DR, Fusey S et al (2007) Vaginal progesterone is associated with a decrease in risk for early preterm birth and improved neonatal outcome in women with a short cervix: a secondary analysis from a randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 30(5):697–705CrossRef
11.
go back to reference Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH, Fetal Medicine Foundation Second Trimester Screening Group (2007) Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med 357(5):462–469CrossRef Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH, Fetal Medicine Foundation Second Trimester Screening Group (2007) Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med 357(5):462–469CrossRef
12.
go back to reference Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M et al (2011) Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 38(1):18–31CrossRef Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M et al (2011) Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol 38(1):18–31CrossRef
13.
go back to reference Gezer A, Rashidova M, Güralp O, Oçer F (2012) Perinatal mortality and morbidity in twin pregnancies: the relation between chorionicity and gestational age at birth. Arch Gynecol Obstet 285(2):353–360CrossRef Gezer A, Rashidova M, Güralp O, Oçer F (2012) Perinatal mortality and morbidity in twin pregnancies: the relation between chorionicity and gestational age at birth. Arch Gynecol Obstet 285(2):353–360CrossRef
14.
go back to reference Challis JRG, Matthews SG, Gibb W, Lye SJ (2000) Endocrine and paracrine regulation of birth at term and preterm. Endocr Rev 21(5):514–550PubMed Challis JRG, Matthews SG, Gibb W, Lye SJ (2000) Endocrine and paracrine regulation of birth at term and preterm. Endocr Rev 21(5):514–550PubMed
15.
go back to reference Norwitz ER, Robinson JN, Challis JR (1999) The control of labor. N Engl J Med 341(9):660–666CrossRef Norwitz ER, Robinson JN, Challis JR (1999) The control of labor. N Engl J Med 341(9):660–666CrossRef
17.
go back to reference Velez Edwards DR, Likis FE, Andrews JC, Woodworth AL, Jerome RN, Fonnesbeck CJ et al (2013) Progestogens for preterm birth prevention: a systematic review and meta-analysis by drug route. Arch Gynecol Obstet 287(6):1059–1066CrossRef Velez Edwards DR, Likis FE, Andrews JC, Woodworth AL, Jerome RN, Fonnesbeck CJ et al (2013) Progestogens for preterm birth prevention: a systematic review and meta-analysis by drug route. Arch Gynecol Obstet 287(6):1059–1066CrossRef
18.
go back to reference Althuisius SM, Dekker GA, Hummel P, Bekedam DJ, van Geijn HP (2001) Final results of the Cervical Incompetence Prevention Randomized Cerclage Trial (CIPRACT): therapeutic cerclage with bed rest versus bed rest alone. Am J Obstet Gynecol 185(5):1106–1112CrossRef Althuisius SM, Dekker GA, Hummel P, Bekedam DJ, van Geijn HP (2001) Final results of the Cervical Incompetence Prevention Randomized Cerclage Trial (CIPRACT): therapeutic cerclage with bed rest versus bed rest alone. Am J Obstet Gynecol 185(5):1106–1112CrossRef
19.
go back to reference da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M (2003) Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol 188(2):419–424CrossRef da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M (2003) Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol 188(2):419–424CrossRef
20.
go back to reference Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH et al (2003) Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med 348(24):2379–2385CrossRef Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH et al (2003) Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med 348(24):2379–2385CrossRef
21.
go back to reference Rouse DJ, Caritis SN, Peaceman AM, Sciscione A, Thom EA, Spong CY et al (2007) A trial of 17 alpha-hydroxyprogesterone caproate to prevent prematurity in twins. N Engl J Med 357(5):454–461CrossRef Rouse DJ, Caritis SN, Peaceman AM, Sciscione A, Thom EA, Spong CY et al (2007) A trial of 17 alpha-hydroxyprogesterone caproate to prevent prematurity in twins. N Engl J Med 357(5):454–461CrossRef
22.
go back to reference Norman JE, Mackenzie F, Owen P, Mactier H, Hanretty K, Cooper S et al (2009) Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis. Lancet 373(9680):2034–2040CrossRef Norman JE, Mackenzie F, Owen P, Mactier H, Hanretty K, Cooper S et al (2009) Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis. Lancet 373(9680):2034–2040CrossRef
23.
go back to reference Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O’Brien JM, Cetingoz E et al (2012) Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol 206(2):124.e1–19CrossRef Romero R, Nicolaides K, Conde-Agudelo A, Tabor A, O’Brien JM, Cetingoz E et al (2012) Vaginal progesterone in women with an asymptomatic sonographic short cervix in the midtrimester decreases preterm delivery and neonatal morbidity: a systematic review and metaanalysis of individual patient data. Am J Obstet Gynecol 206(2):124.e1–19CrossRef
24.
go back to reference Schuit E, Stock S, Rode L, Rouse DJ, Lim AC, Norman JE et al (2015) Effectiveness of progestogens to improve perinatal outcome in twin pregnancies: an individual participant data meta-analysis. BJOG 122(1):27–37CrossRef Schuit E, Stock S, Rode L, Rouse DJ, Lim AC, Norman JE et al (2015) Effectiveness of progestogens to improve perinatal outcome in twin pregnancies: an individual participant data meta-analysis. BJOG 122(1):27–37CrossRef
25.
go back to reference Conde-Agudelo A, Romero R, Hassan SS, Yeo L (2010) Transvaginal sonographic cervical length for the prediction of spontaneous preterm birth in twin pregnancies: a systematic review and metaanalysis. Am J Obstet Gynecol 203(2):128.e1–12CrossRef Conde-Agudelo A, Romero R, Hassan SS, Yeo L (2010) Transvaginal sonographic cervical length for the prediction of spontaneous preterm birth in twin pregnancies: a systematic review and metaanalysis. Am J Obstet Gynecol 203(2):128.e1–12CrossRef
26.
go back to reference Zanardini C, Pagani G, Fichera A, Prefumo F, Frusca T (2013) Cervical cerclage in twin pregnancies. Arch Gynecol Obstet 288(2):267–271CrossRef Zanardini C, Pagani G, Fichera A, Prefumo F, Frusca T (2013) Cervical cerclage in twin pregnancies. Arch Gynecol Obstet 288(2):267–271CrossRef
Metadata
Title
RETRACTED ARTICLE: Vaginal progesterone for prevention of preterm labor in asymptomatic twin pregnancies with sonographic short cervix: a randomized clinical trial of efficacy and safety
Authors
Waleed El-refaie
Mohamed S. Abdelhafez
Ahmed Badawy
Publication date
01-01-2016
Publisher
Springer Berlin Heidelberg
Published in
Archives of Gynecology and Obstetrics / Issue 1/2016
Print ISSN: 0932-0067
Electronic ISSN: 1432-0711
DOI
https://doi.org/10.1007/s00404-015-3767-1

Other articles of this Issue 1/2016

Archives of Gynecology and Obstetrics 1/2016 Go to the issue