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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

  1. E. A. De Franco1,*,
  2. J. M. O'Brien2,
  3. C. D. Adair3,
  4. D. F. Lewis4,
  5. D. R. Hall5,
  6. S. Fusey6,
  7. P. Soma-Pillay7,
  8. K. Porter8,
  9. H. How9,
  10. R. Schakis10,
  11. D. Eller11,
  12. Y. Trivedi12,
  13. G. Vanburen13,
  14. M. Khandelwal14,
  15. K. Trofatter15,
  16. D. Vidyadhari16,
  17. J. Vijayaraghavan17,
  18. J. Weeks18,
  19. B. Dattel19,
  20. E. Newton20,
  21. C. Chazotte21,
  22. G. Valenzuela22,
  23. P. CAlda23,
  24. M. Bsharat24,
  25. G. W. Creasy25

Article first published online: 26 SEP 2007

DOI: 10.1002/uog.5159

Issue

Ultrasound in Obstetrics & Gynecology

Ultrasound in Obstetrics & Gynecology

Volume 30, Issue 5, pages 697–705, October 2007

Additional Information

How to Cite

De Franco, E. A., O'Brien, J. M., Adair, C. D., Lewis, D. F., Hall, D. R., Fusey, S., Soma-Pillay, P., Porter, K., How, H., Schakis, R., Eller, D., Trivedi, Y., Vanburen, G., Khandelwal, M., Trofatter, K., Vidyadhari, D., Vijayaraghavan, J., Weeks, J., Dattel, B., Newton, E., Chazotte, C., Valenzuela, G., CAlda, P., Bsharat, M. and Creasy, G. W. (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: 697–705. doi: 10.1002/uog.5159

Author Information

  1. 1

    Department of Obstetrics and Gynecology and Center for Preterm Birth Research, Washington University School of Medicine, St. Louis, Missouri, USA

  2. 2

    Perinatal Diagnostic Center, Central Baptist Hospital, Lexington, Kentucky, USA

  3. 3

    University of Tennessee College of Medicine, Chattanooga, Tennessee, USA

  4. 4

    Department of Obstetrics and Gynecology, Louisiana State University Health Sciences Center, Shreveport, Louisiana, USA

  5. 5

    Department of Obstetrics and Gynaecology, Stellenbosch University and Tygerberg Hospital, Tygerberg, South Africa

  6. 6

    Department of Obstetrics and Gynaecology, Government Medical College, Nagpur, India

  7. 7

    Department of Obstetrics and Gynaecology, University of Pretoria, Pretoria, South Africa

  8. 8

    University of South Alabama, Mobile, Alabama, USA

  9. 9

    University of Cincinnati, Cincinnati, Ohio, USA

  10. 10

    Chris Hani Baragwanath Hospital, University of the Witwatersrand, Soweto, South Africa

  11. 11

    Maternal Fetal Specialists, Atlanta, Georgia, USA

  12. 12

    Department of Obstetrics and Gynecology, Sheth Vadilal Sarabhai General Hosptial, Gujarat, India

  13. 13

    University Hospitals Case Medical Center, Cleveland, Ohio, USA

  14. 14

    Cooper Hospital, Camden, New Jersey, USA

  15. 15

    University Medical Group, Greenville, South Carolina, USA

  16. 16

    MediCiti Institute of Medical Sciences, Andra Pradesh, India

  17. 17

    Sri. Ramchandra Hospital, Chennai, India

  18. 18

    Norton Healthcare, Louisville, Kentucky, USA

  19. 19

    Department of Obstetrics and Gynecology, Eastern Virginia Medical School, Norfolk, Virgina, USA

  20. 20

    Brody School of Medicine, East Carolina University, Greenville, North Carolina, USA

  21. 21

    Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, USA

  22. 22

    Arrowhead Regional Medical Center, Colton, California, USA

  23. 23

    Department of Obstetrics and Gynaecology, First Medical School, Charles University, Prague, Czech Republic

  24. 24

    Quintiles Biostatistics, Overland Park, Kansas, USA

  25. 25

    Columbia Laboratories, Inc., Livingston, New Jersey, USA

*Washington University School of Medicine, Department of Obstetrics and Gynecology, 4566 Scott, Avenue, Campus Box 8064, St. Louis, Missouri 63110, USA

Publication History

  1. Issue published online: 26 SEP 2007
  2. Article first published online: 26 SEP 2007
  3. Manuscript Accepted: 20 AUG 2007

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Keywords:

  • pregnancy;
  • prematurity;
  • preterm birth;
  • progesterone;
  • short cervix

Abstract

Objective

To investigate the efficacy of vaginal progesterone to prevent early preterm birth in women with sonographic evidence of a short cervical length in the midtrimester.

Methods

This was a planned, but modified, secondary analysis of our multinational, multicenter, randomized, placebo-controlled trial, in which women were randomized between 18 + 0 and 22 + 6 weeks of gestation to receive daily treatment with 90 mg of vaginal progesterone gel or placebo. Cervical length was measured with transvaginal ultrasound at enrollment and at 28 weeks of gestation. Treatment continued until either delivery, 37 weeks of gestation or development of preterm rupture of membranes. Maternal and neonatal outcomes were evaluated for the subset of all randomized women with cervical length < 28 mm at enrollment. The primary outcome was preterm birth at ≤ 32 weeks.

Results

A cervical length < 28 mm was identified in 46 randomized women: 19 of 313 who received progesterone and 27 of 307 who received the placebo. Baseline characteristics of the two groups were similar. In women with a cervical length < 28 mm, the rate of preterm birth at ≤ 32 weeks was significantly lower for those receiving progesterone than it was for those receiving the placebo (0% vs. 29.6%, P = 0.014). With progesterone, there were fewer admissions into the neonatal intensive care unit (NICU; 15.8% vs. 51.9%, P = 0.016) and shorter NICU stays (1.1 vs. 16.5 days, P = 0.013). There was also a trend toward a decreased rate of neonatal respiratory distress syndrome (5.3% vs. 29.6%, P = 0.060).

Conclusion

Vaginal progesterone may reduce the rate of early preterm birth and improve neonatal outcome in women with a short sonographic cervical length. Copyright © 2007 ISUOG. Published by John Wiley & Sons, Ltd.

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