Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of Oral Progesterone and Vaginal Progesterone After Tocolytic Therapy in Threatened Preterm Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02989519
Recruitment Status : Completed
First Posted : December 12, 2016
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Piyawadee Wuttikonsammakit, Sanpasitthiprasong Hospital

Brief Summary:
The purpose of this study is to determine efficacy of vaginal and oral progesterone after tocolytic therapy in threatened preterm labor

Condition or disease Intervention/treatment Phase
Preterm Delivery Drug: dydrogesterone Drug: Micronized progesterone Phase 3

Detailed Description:
A randomized controlled trial was conducted from August 2015 through December 2016. All pregnant women with single pregnancies of 28 to 33 weeks and 6 days who had been experienced for threatened or preterm labor with intact membrane as in inclusion criteria were approached and ask for enrollment. The gestational age of all patients was confirmed by antenatal record review and ultrasonographic confirmation. Threatened preterm labor was defined as the presence of regular uterine contractions without significant cervical changes as determined by digital pelvic examination. Preterm labor was defined as the simultaneous presence of regular uterine contractions and cervical changes, shortening and/or softening, or dilatation, as determined by digital pelvic examination. The women with preterm labor underwent standard tocolysis, which was administered for at least 48 hours, to allow corticosteroid promote fetal lung maturation. The patients who had proven membranes ruptured, and ultrasonographically found placenta previa, multiple pregnancy, fetal anomaly or aneuploidy would excluded. The participants had emergency condition that required for emergency delivery such as fetal distress, chorioamnionitis were also excluded. Participants were randomized into three groups which generated by computer programme to receive whether oral progesterone (dydrogesterone 10 mg; Duphaston™) per oral three times a day or vaginal progesterone (micronized progesterone 200 mg; Utrogestan™) or no progesterone (controlled group). All patients were digitally pelvic examined for evaluation of Bishop score and assessed cervical length by transvaginal ultrasound at enrollment and follow up visit at two weeks apart. Cervical length was measured by standard technique with a covered probe inserted into vagina after each woman had emptied her bladder. Excessive pressure on cervix was avoided. The mean value of 3 consecutive measurements was used for analysis. Informed consent and demographic data were obtained at the enrollment. Primary outcomes were preterm delivery before 34 and 37 weeks. Secondary outcomes include time until delivery (latency period,days), change of cervical length (cervical attenuation), maternal outcome, neonatal outcome, and side effects of drugs were collected. The main outcomes of preterm delivery, gestational age at parturition and birthweight were also collected by telephone call in case of out-side-hospital born or in case loss to follow up. Monitoring of all patients was evaluated every follow up visit for drug side effect, allergic response, and adverse events Statistical analysis Sample size was calculated according to the results of two studies by Dorota AgataBomba - Opon and Manju Choudhary which showed significant decreased preterm delivery <34 weeks (9.8% vs 35.3%,p=0.002) in vaginal progesterone group, and significant decreased preterm birth (33% vs 58% ; p= 0.034) in oral progesterone group. The sample size of 231 was used to evaluate the primary outcome of both drugs. Descriptive statistics were carried out using mean, median, standard deviation, interquartile range. Categorical data were tested for significance with the χ2tests. Continuous data were evaluated for normal distribution and tested for significance with ANOVA and Kruskal-Wallis test. Student t test and Man-Whitney U test were used to test significance between groups in case there is significant detection in ANOVA and Kruskal-Wallis test among groups. Statistical significance was defined as p<0.05.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of the Efficacy of Oral Progesterone and Vaginal Progesterone After Tocolytic Therapy in Threatened Preterm Labor
Actual Study Start Date : August 2015
Actual Primary Completion Date : January 5, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: no progesterone
All women with preterm labor underwent standard tocolysis, which was administered for at least 48 hours, to allow corticosteroid promote fetal lung maturation
Experimental: oral progesterone
All women with preterm labor underwent standard tocolysis, which was administered for at least 48 hours, to allow corticosteroid promote fetal lung maturation. All women in this arm received oral progesterone (dydrogesterone 10 mg; Duphaston™) per oral three times a day
Drug: dydrogesterone
Other Name: Duphaston

Experimental: vaginal progesterone
All women with preterm labor underwent standard tocolysis, which was administered for at least 48 hours, to allow corticosteroid promote fetal lung maturation. All women in this arm received vaginal progesterone (micronized progesterone 200 mg; Utrogestan™) at bed time.
Drug: Micronized progesterone
Other Name: Utrogestan




Primary Outcome Measures :
  1. preterm delivery before 34 and 37 weeks [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. change of cervical length [ Time Frame: 2 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Single pregnancies of 28 to 33 weeks and 6 days who had been experienced for threatened or preterm labor with intact membrane

Exclusion Criteria:

  • Proven membranes ruptured
  • Ultrasonographically found placenta previa, multiple pregnancy, fetal anomaly
  • Aneuploidy detected.
  • Had emergency condition that required for emergency delivery such as fetal distress, chorioamnionitis, prolapsed cord

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): NCT02989519


Locations
Layout table for location information
Thailand
Piyawadee Wuttikonsammakit
Nai Muang, Ubon Ratchathani, Thailand, 34000
Sponsors and Collaborators
Sanpasitthiprasong Hospital
Investigators
Layout table for investigator information
Principal Investigator: Piyawadee Wuttikonsammakit, MD Instructor

Layout table for additonal information
Responsible Party: Piyawadee Wuttikonsammakit, Instructor, Sanpasitthiprasong Hospital
ClinicalTrials.gov Identifier: NCT02989519     History of Changes
Other Study ID Numbers: SPS2016-01
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Piyawadee Wuttikonsammakit, Sanpasitthiprasong Hospital:
preterm labor
progesterone efficacy
threatened preterm labor

Additional relevant MeSH terms:
Layout table for MeSH terms
Progesterone
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Dydrogesterone
Tocolytic Agents
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents