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Progesterone and Aminophylline for the Prevention of Preterm Labour (PROGRAM)

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ClinicalTrials.gov Identifier: NCT03152942
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Action Medical Research
Information provided by (Responsible Party):
St Stephens Aids Trust

Brief 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.


Condition or disease Intervention/treatment Phase
Premature Obstetric Labor Drug: Progesterone Drug: Aminophylline Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Feasibility Study of the Tolerability of the Combination of Progesterone and Aminophylline for the Prevention of Preterm Labour
Actual Study Start Date : October 5, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Progesterone alone
Progesterone 400 mg once daily until 34 weeks.
Drug: Progesterone
Progesterone 400mg to be administered once daily for 34 weeks in the patients randomised to receive progesterone alone
Other Name: Cyclogest

Active Comparator: Progesterone and aminophylline.
Progesterone 400 mg and aminophylline 225 mg once daily until 34 weeks.
Drug: Progesterone
Progesterone 400mg to be administered once daily for 34 weeks in the patients randomised to receive progesterone alone
Other Name: Cyclogest

Drug: Aminophylline
Patients randomised to the combination arm to be administered aminophylline 225 mg to be taken once at night for 1 week and then if tolerated increased to 225 mg twice daily Progesterone 400mg to be administered once daily for 34 weeks.
Other Name: Phyllocontin® Continus®




Primary Outcome Measures :
  1. To assess number of 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. [ Time Frame: 34 weeks ]
    Tolerability will be assessed by the number of participants who withdraw from the study due to severe adverse side effects at each safety visit (14, 16, 18, 22, 26, 30 and 34 weeks of pregnancy).


Secondary Outcome Measures :
  1. To assess the effect on the maternal immune system. [ Time Frame: 34 weeks ]
    By studying cervicovaginal swabs taken every 4 weeks, blood tests, and measuring levels of cytokine and chemokine inflammatory profile.

  2. The impact on preterm delivery and episodes of threatened Preterm Labour [ Time Frame: 34 weeks ]
    This will be measured by number of preterm deliveries and reported side effects between the two groups on combination and mono therapy.

  3. The number of women who deliver before 34 weeks. [ Time Frame: 34 weeks ]
    Measuring the number of patients who deliver before 34 weeks.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03152942


Contacts
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Contact: Project Manager Mailbox +44 (0) 203 828 0569 SSAT068@ststcr.com
Contact: Marita Marshall +44 (0) 7825 429 337 marita.marshall@ststcr.com

Locations
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United Kingdom
Chelsea and Westminster Hospital Recruiting
London, United Kingdom, SW10 9TH
Contact: Mark Johnson    +44 (0) 203 315 7892    mark.johnson@imperial.ac.uk   
Sub-Investigator: Natasha Singh         
Sponsors and Collaborators
St Stephens Aids Trust
Action Medical Research
Investigators
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Principal Investigator: Mark Johnson, Professor Chelsea and Westminster Hospital

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Responsible Party: St Stephens Aids Trust
ClinicalTrials.gov Identifier: NCT03152942     History of Changes
Other Study ID Numbers: SSAT068
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Progesterone
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Aminophylline
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Protective Agents