Premature Obstetric Labor Clinical Trial
Official title:
A Randomised Controlled Feasibility Study of the Tolerability of the Combination of Progesterone and Aminophylline for the Prevention of Preterm Labour
The aim of this study is to investigate whether the combination of aminophylline and
Progesterone (P4) is acceptable to women at high-risk of Pre-term labour (PTL). If this
proves to be the case, a larger double blind, randomised controlled trial will be conducted
to test the hypothesis that the combination of P4 and aminophylline reduces the risk of PTL
more effectively than P4 alone.
The study is a randomised study where participants will be either administered a combination
of aminophylline and Progesterone (P4) or Progesterone (P4) alone.As the study is open label,
the participants and the study doctor will know which study medications the participant is
taking at all times during the study.
Name of Investigational Product: Cyclogest® 400 mg, Phyllocontin® Continus®
Name of active ingredients:Progesterone PhEur 400 mg, Aminophylline hydrate 225 mg
Phase of study: Phase I
Primary Objectives:
1. To assess how many women at high risk of Preterm Labour (PTL) withdraw from the
combination therapy of Progesterone (P4) and aminophylline due to side effects in comparison
to P4 alone.
Secondary Objectives:
1. The effect on the maternal immune system.
2. The impact on preterm delivery and episodes of threatened PTL.
3. The number of women who deliver before 34 weeks.
Methodology:
This randomised controlled feasibility study will establish the viability of conducting a
multicentre randomised controlled study to definitively test the effects of the combination
of Progesterone (P4) and aminophylline against P4 alone.
Participants (n=70) will be randomised into one of two groups. One group will receive P4
alone while the second group will receive a combination of P4 and aminophylline. Following
randomisation to P4 alone or in combination with aminophylline, participants will be given a
prescription to be taken to the pharmacy.
All participants will be given a prescription for P4 400 mg to be inserted into the vagina at
bedtime until 34 weeks.
Participants randomised to the combined arm will also be given a prescription for
aminophylline 225 mg to be taken once at night for 1 week and then if tolerated increased to
225 mg twice daily.
Subjects will attend the unit for 34 weeks for clinical review and safety monitoring.
Treatment will be continued until 34 weeks of gestation or until preterm delivery (whichever
occurs first).
During the safety visits, flow cytometry will be used to determine inflammatory cell numbers
and their activation status in cervical and blood samples.
Cervico-vaginal fluid and peripheral blood plasma will also be stored at - 80oC until
multiplex analysis of cytokine and chemokine content.
Summary of eligibility criteria:
- Obstetric history: previous mid-trimester loss and preterm delivery
- Short cervical length (≤ 25 mm) on ultrasound at 13-20+0 weeks gestation, with or
without a cervical suture and with or without a positive fetal fibronectin
- Women must be aged 18 years or older
Primary Endpoint:
1. The number of women maintained on the combination therapy P4 and aminophylline arm and the
P4 alone alrm up to 34 weeks of treatment. A positive outcome would be seeing 80% or more
women maintained on therapy.
Secondary Endpoint:
1. The effects on the maternal immune system.
2. The number of women who deliver before the end of the study (34 weeks).
3. The impact on preterm delivery and episodes of threatened PTL.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05412056 -
Metformin to Prevent Preterm Birth in Twin Pregnancy
|
Phase 2/Phase 3 |