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Trial record 14 of 2076 for:    ESTRADIOL

Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

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ClinicalTrials.gov Identifier: NCT02485821
Recruitment Status : Completed
First Posted : June 30, 2015
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Mohamed S Sweed, MD, Ain Shams University

Brief Summary:
To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor induction.

Condition or disease Intervention/treatment Phase
Failed Induction of Labor Drug: Estradiol Drug: Placebo Drug: Misoprostol Phase 2 Phase 3

Detailed Description:

A prospective double blind randomized clinical trial. Conducted at Ain Shams University Maternity Hospital. Patients fulfilling inclusion and exclusion criteria will be divided into two groups. Group (A):

100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses.

Group (B):

100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.

Primary Outcome

  • Measure the time to cervical ripening. Secondary Outcome
  • Measure the time to active labor.
  • Number of misoprostol doses.
  • Induction delivery time.
  • Time to achieve vaginal delivery.
  • Fetal outcome (Apgar score).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol
Study Start Date : June 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016


Arm Intervention/treatment
Experimental: Estradiol + Misoprostol
100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses.
Drug: Estradiol
Other Name: Ethinyl Estradiol

Drug: Misoprostol
Other Name: Vagiprost

Placebo Comparator: Placebo + Misoprostol
100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.
Drug: Placebo
Drug: Misoprostol
Other Name: Vagiprost




Primary Outcome Measures :
  1. Time to cervical ripening. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Time to active labor [ Time Frame: 30 hours ]
  2. Number of misoprostol doses [ Time Frame: 24 hours ]
  3. Induction delivery time [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Maternal age ≥ 18 years old.
  • Gestational age ≥ 37 wks to 41 wks.
  • BMI between 20 kg/m2 and 35kg/m2.
  • Vertex presentation.
  • Singleton pregnancy.

Exclusion criteria:

  • Multiple pregnancy.
  • Non vertex presentation.
  • Absolute or relative contraindication to vaginal delivery e.g. (Placenta previa, fibroid uterus, uterine anomalies, previous uterine surgery).
  • PROM.
  • IUFD.
  • Fetal distress.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02485821


Locations
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Egypt
Ain Shams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Osama El-Kady, MD AinShams University
Principal Investigator: AbdEl-Latif El-Kholy, MD AinShams University

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Responsible Party: Mohamed S Sweed, MD, Mohamed S. Sweed lecturer of Obstetrics & Gynecology AinShams University., Ain Shams University
ClinicalTrials.gov Identifier: NCT02485821     History of Changes
Other Study ID Numbers: MS39825273
First Posted: June 30, 2015    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Keywords provided by Mohamed S Sweed, MD, Ain Shams University:
Estradiol
Misoprostol
Induction of labor
Cervical ripening
Bishop score
Additional relevant MeSH terms:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Misoprostol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics