The Effect of Sulfasalazine on CRH Levels in Pregnant Women
ConditionPreterm Birth
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRutgers, The State University of New Jersey
About this trial
The goal of this randomized clinical trial is to assess sulfasalazine as a potential treatment to prevent recurrent preterm birth. The main questions it aims to answer are:
* Does sulfasalazine down regulate corticotropin releasing hormone (CRH) levels in pregnant persons with a prior history of preterm birth? * Does sulfasalazine reduce the incidence of recurrent preterm birth in pregnant persons given drug vs. controls?
Consenting participants will be randomized to receive sulfasalazine or to a control group and will undergo serial blood draws to assess plasma CRH levels.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
> 18 years of age
Singleton pregnancy
Participants with a history of prior preterm birth in a previous pregnancy
Participants must be between 12 and 22 weeks gestation.
Disqualifiers
Participants < 18 years old
Participants with a cervical length < 25 mm
Participants with a multiple gestation
Cerclage
Trial design
Design model
Sequential
Treatments tested in this trial
Sulfasalazine
DrugSulfasalazine will be administered between 24 and 36 weeks of pregnancy
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: SulfasalazineExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Serum CRH levels
CRH will be assessed at 28, 32, and 36 weeks gestation
Time frame
between 28 and 36 weeks of pregnancySecondary outcomes
1
Spontaneous preterm birth < 37 weeks gestation
Preterm births prior to 37 weeks secondary to preterm labor (PTL) or premature Preterm births secondary to preterm labor or preterm rupture of the membranes (PPROM)
Time frame
up to 37 weeks of pregnancy2
Spontaneous preterm birth < 34 weeks gestation
Preterm births prior to 34 weeks secondary to PTL or PPROM
Time frame
up to 34 weeks of pregnancy3
Medically indicated preterm birth < 37 weeks gestation
Preterm births due to maternal or fetal disease not related to PTL or PPROM
Time frame
up to 37 weeks of pregnancy4
Digital cervical exam at 36 weeks gestational age
Digital cervical exam at 36 weeks gestational age
Time frame
between 35 weeks and 36 weeks 6 days of pregnancySponsors and contacts
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Source ClinicalTrials.gov