Protocol summary
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Study aim
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Comparison of oral and intramuscular progesterone in preterm labor
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Design
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In this clinical trial with phase 2-3, with two intervention groups and without any control group, 146 patients divides randomly into two groups of 73. The study will be done as single blind study.
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Settings and conduct
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Weekly, all the patients of two groups are followed up in the gynecology clinic of Afzalipour hospital. After delivery, delivery condition and time, delivery method, newborn weight, APGAR score and the need for NICU hospitalization are investigated. The complications followed by each of oral and injectable medications are registered. Regarding the study being single blinded, patients, physicians and midwives are aware of the treatment type and just the data analyzer is blind to the medication type.
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Participants/Inclusion and exclusion criteria
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Inclusion: preterm labor, single pregnancy, live fetus, healthy amniotic sac, gestation age (24-36 weeks), lack of cerclage, labor pains, cervical dilatation ≥1 cm.
Exclusion: PPROM, vaginal bleeding, cervical dilation >3 cm, fetal death or distress, maternal systemic diseases, known uterine anomalies, history of taking any medication other than the usual supplements, polyhydramnios and oligohydramnios, fetal anomaly, suspicion of intrauterine infection, being dangerous for the mother to continue the pregnancy, lack of cooperation of mothers.
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Intervention groups
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In the intervention group one, patient received a 200 mg capsule of luteogel daily containing micronized progesterone by Tesnim company, and in the second intervention group, patients received a weekly proletone 250 mg ampoule product of Bayer company treatment continued until delivery or 36 weeks. Patients are visited weekly.
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Main outcome variables
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Birth weight, gestational age at delivery, frequency of preterm labor in each group, duration of latency and frequency of admitted infants in each group
General information
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Reason for update
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In the sample size section, the number of samples in each group was written, which was corrected and the total sample size was 146 people.
This study was randomized and modified in the relevant section.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190623043981N1
Registration date:
2020-05-04, 1399/02/15
Registration timing:
retrospective
Last update:
2021-12-21, 1400/09/30
Update count:
3
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Registration date
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2020-05-04, 1399/02/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-02-23, 1397/12/04
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Expected recruitment end date
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2019-09-22, 1398/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of pregnancy outcome following oral and intramuscular progesterone use in preterm labor
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Public title
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Comparison of oral and intramuscular progesterone in preterm labor
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Single-tone pregnancy
alive fetus
intact membrane
gestational age between 24-36 weeks
preterm labor
lack of cerclage
labor pains in the form of contractions alternating 2 times in 10 minutes or 8 times in 60 minutes
cervical dilatation equal to or greater than 1 cm
ultrasound of the first 3 months of pregnancy
Exclusion criteria:
vaginal bleeding
known uterine anomalies
fetal anomalies
suspicion of intrauterine infection
preterm premature rupture of membranes (PPROM)
cervical dilation greater than 3 cm
fetal death or fetal distress
maternal systemic diseases
history of taking any medication other than the usual supplements during pregnancy
polyhydramnios and oligohydramnios
being dangerous for the mother to continue the pregnancy due to medical reasons
lack of cooperation of mothers during study
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Age
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No age limit
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
146
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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After stopping labor pain successfully, 146 patients in the form of randomization allocation are divided into to two groups (A= 73 and B= 73) according to random number table. This study was performed as a single-blind study. The patient and physician were aware of the type of treatment and only the person evaluating the data was unaware of the type of treatment at the end. The statistical consultant performed randomization and provided the results to the researcher and the researcher assigned the participants to the interventions groups.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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during this study, the data evaluator was unaware of the treatment types, while physician and patient blinding was impossible as the difference of the used methods was obvious to the them.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-02-22, 1397/12/03
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Ethics committee reference number
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IR.KMU.AH.REC.1397.155
Health conditions studied
1
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Description of health condition studied
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Preterm labour
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ICD-10 code
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O60.0
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ICD-10 code description
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Preterm labour without delivery
Primary outcomes
1
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Description
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Birth weight
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Timepoint
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after delivery
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Method of measurement
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Scale
2
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Description
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gestational age at delivery
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Timepoint
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after delivery
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Method of measurement
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patient documents
3
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Description
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latency period
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Timepoint
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from beginning of intervention until delivery
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Method of measurement
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patient documents
4
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Description
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number of hospitalized neonates in each group
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Timepoint
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after delivery
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Method of measurement
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patient documents
Intervention groups
1
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Description
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In the intervention group one, until 36 weeks of pregnancy, 200 mg capsule containing micronized progesterone called luteogel produced by Tasnim company will be given daily .
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Category
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Treatment - Drugs
2
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Description
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Intervention group two a 250 mg progesterone ampoule containing hydroxy caproate produced of Byer company will be given weekly and treatment will continue until 36 weeks of pregnancy.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kerman University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Total data
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When the data will become available and for how long
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Starting six months after the publication of the article
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To whom data/document is available
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Researchers, students and doctors
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Under which criteria data/document could be used
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To perform clinical examination
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From where data/document is obtainable
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General or scientific responsible person
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What processes are involved for a request to access data/document
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Submit the proposal to the responsible person
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Comments
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