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A clinical study to evaluate the safety of combination therapy with medroxyprogesterone acetate in patients receiving ritodrine hydrochloride for threatened preterm labor

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Threatened preterm labor
Date of first enrollment	07/11/2025
Target sample size	10
Countries of recruitment
Study type	Interventional
Intervention(s)	Patients receiving continuous intravenous infusion of ritodrine hydrochloride for threatened preterm labor will be administered one tablet (2.5 mg) of Provera orally after each meal (total 7.5 mg/day).

Outcome(s)

Primary Outcome

Information will be collected on the number and details of maternal adverse events considered to be side effects of medroxyprogesterone acetate (MPA) and ritodrine hydrochloride, within the safety analysis population. A comparative analysis will be conducted using patients who received ritodrine hydrochloride for threatened preterm labor at our institution between January 2015 and December 2024 as the control group.

Secondary Outcome

1. Preterm birth rate 2. Changes in maternal serum inflammatory markers (e.g., white blood cell count, CRP, Galectin-3, etc.) 3. Total dose and duration of ritodrine hydrochloride administration

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include criteria	Patients who meet all of the following criteria will be included 1. Patients diagnosed with threatened preterm labor between 28 weeks 0 days and 33 weeks 6 days of gestation. Diagnosis of threatened preterm labor is defined by the presence of at least one of the following (1) At least six uterine contractions within one hour, (2) progressive cervical dilation or effacement, or (3) genital bleeding. 2. Patients with a singleton pregnancy. 3. Patients who are 18 years of age or older at the time of obtaining informed consent. 4. Patients who have initiated tocolytic therapy with ritodrine hydrochloride for threatened preterm labor.
Exclude criteria	Patients who meet any of the following criteria will be excluded from this study 1. Patients with preterm premature rupture of membranes (PPROM). 2. Patients with placenta previa. 3. Patients suspected of having intrauterine infection, such as chorioamnionitis. 4. Patients with threatened uterine rupture. 5. Patients carrying a fetus with fetal growth restriction (FGR). 6. Patients with a fetus diagnosed with congenital anomalies for which preterm delivery is deemed appropriate. 7. Patients with a personal or family history of thrombotic predisposition or thrombophilia. 8. Patients with a history or current diagnosis of thrombotic disorders, such as cerebral infarction, myocardial infarction, or deep vein thrombosis. 9. Patients with severe hepatic dysfunction or liver disease. 10. Patients with a known history of hypersensitivity to components of medroxyprogesterone acetate (MPA). 11. Patients deemed inappropriate for study participation by the principal investigator or sub-investigators.