Progesterone and Aminophylline for the Prevention of Preterm Labour

• Status: Unknown status
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St Stephens Aids Trust
• Collaborator: Action Medical Research
• Treatments: Aminophylline; Progesterone

Criteria

Inclusion Criteria:

1. Pregnant women between 13 and 20 weeks of gestation.

2. Singleton pregnancy.

3. Intact fetal membranes at the time of recruitment.

4. The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.

5. Obstetric history: previous mid-trimester loss (14 - 26 weeks) and preterm delivery (< 37 weeks).

6. Women with a history of indicated cervical suture.

7. 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.

8. Women must be aged 18 years or older.

Exclusion Criteria:

1. Known sensitivity, contraindication or intolerance to P4 (History of liver tumours, severe liver impairment, genital or breast cancer, severe arterial disease, undiagnosed vaginal bleeding, acute porphyria, history during pregnancy of idiopathic jaundice, severe pruritus or pemphigoid gestations)

2. Known sensitivity, contraindication or intolerance to aminophylline (hypokalaemia, pre-existing cardiac arrhythmias, epilepsy, hyperparathyroidism, peptic ulcer disease)

3. Suspected or proven rupture of the fetal membranes at the time of recruitment.

4. Prescription or ingestion of medications known to interact with P4 (e.g Bromocriptine, carbamazepine, diazepam, lorazepam and temazepam, insulin).

5. Aminophylline plasma concentrations can be increased in the presence of: acyclovir, calcium channel blockers, cimetidine, erythromycin, clarithromycin, corticosteroids and benzodiazepine, carbamazepine, beta-sympathomimetics.

6. Evidence of maternal infection or sepsis (maternal temperature ≥37.5C, increased inflammatory markers - WBC, CRP).

7. Multiple pregnancy.

8. Known significant congenital structural or chromosomal fetal anomaly.

9. Maternal pathologies in which preterm termination of pregnancy is required.

10. Pre-eclampsia or severe hypertension.