Condition category
Pregnancy and Childbirth
Date applied
25/05/2014
Date assigned
18/07/2014
Last edited
18/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Preterm premature rupture of the membranes (PPROM) is a problem directly linked to prematurity that can cause severe newborn complications and even death. Research has shown that weekly injections of 17-alpha-hydroxyprogesterone (17P) or daily progesterone application in the vagina decreases the number of preterm deliveries, notably in those with a history of a prior preterm delivery and those with a shortened cervix discovered by ultrasound examination. Infection stimulates the production of pro-inflammatory cytokines that are commonly associated with preterm birth and PPROM. Studies have suggested that 17P can maintain pregnancy and prevent PPROM. Furthermore, no studies have yet been conducted to see the effect of vaginal or rectal progesterone on latency period (defined as the period from the onset of PROM until onset of labour). The safety of using vaginal progesterone in PPROM is questionable; thus, the vaginal route will be replaced by the rectal route. Our primary aim is to study the effect of rectal progesterone on the latency period of PPROM.

Who can participate?
Women aged 18-45 years old who are between 24 and 33 weeks pregnant, with a confirmed diagnosis of PPROM.

What does the study involve?
The patients will be randomly allocated to receive either rectal progesterone or a placebo (dummy) suppository on a daily basis. Daily rectal progesterone or placebo suppository continue until 35 weeks or delivery, whichever comes first. Patients, their families, research personnel, and physicians/nurses will not be aware of the study group assignment. Women will be given a 7-day course of antibiotics and will receive full courses of steroids for foetal lung maturation. After their stay in the labour and delivery area, patients will be transferred to the high-risk floor. All patients will have vaginal swab testing, routine foetal testing and frequent assessments for infection. All patients will stop therapy at 35 weeks. There will be no additional visits or costs due to the study itself.

What are the possible benefits and risks of participating?
The study drug has no side effects except for the minor possibility of an allergic reaction in rare cases. Refusing to participate in the study will not affect the patient’s medical care. Patients will have the right to withdraw from the study at any point.

Where is the study run from?
The study will be carried out at the following four centers in Jeddah, Saudi Arabia:

1. King Abdulaziz University Hospital (KAU Hospital)
2. Dr.Soliman Fakeeh Hospital
3. King Faisal specialist hospital and Research Center (KFSH&RC)
4. International Medical Center


When is study starting and how long is it expected to run for?
Recruitment starts in July 2014 and will continue over a period of 7 months.

Who is funding the study?
Institute of Scientific Research and Revival of Islamic Heritage, Umm Al-Qura University, Saudi Arabia.

Who is the main contact?
Dr Fadawh Tahir, Fadwaht@gmail.com
Prof. Muhammad Irfanullah Siddiqui, irfan7255@yahoo.com, irfan7255@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fadwah Tahir

ORCID ID

Contact details

Jeddah- Al Nozlah
Jeddah
21478
Saudi Arabia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

30

Study information

Scientific title

The effect of rectal progesterone on the latency period as well as maternal and prenatal outcome in PPROM between 24-33+6 Weeks

Acronym

PPROM

Study hypothesis

It is hypothesized that rectal progesterone can prevent preterm labor, which in turn reduces fetal mortality and morbidity. The null hypothesis is that there will be no difference between the placebo group and the rectal progesterone group.

Ethics approval

Ethics Committee of Faculty of Medicine, Umm Al-Qura University, 17/02/2014, ref: 14/BME/0030

Study design

Multi-centre triple-blinded randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Preterm premature rupture of membrane (PPROM)

Intervention

Rectal progesterone (Cyclogest) and placebo

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To determine the effect of rectal progesterone on the Latency Period in PPROM. The outcomes will be measured using three forms: recruitment form, follow-up form, and research end form. These forms where designed by the authors using focused group discussion. These forms will be completed by the treating physicians. The recruitment and the research end forms will be completed only once, when the patient agrees to participate in the study and when the patient is discharged from our care, respectively. The follow-up form will be filled twice weekly.

Secondary outcome measures

To find out the effect of rectal progesterone on maternal outcomes of:
1. Hospitalization
2. ICU admission
3. Chorioamnionitis
4. Post-partum haemorrhage
5. Post-partum pyrexia
6. Endometritis
7. Maternal death

Prenatal outcome of:
1. Birth weight
2. Apgar score
3. Neonatal morbidity
4. Neonatal intensive care unit (NICU) stay
5. Intrauterine fetal death (IUFD)
6. Neonatal death in PPROM

Overall trial start date

01/06/2013

Overall trial end date

01/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18-45 years old
2. Singleton live fetus
3. 24 to 33 weeks
4. Confirmed PPROM

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

216

Participant exclusion criteria

All fetal & maternal conditions that could affect fetal and maternal outcomes

Maternal:
1. Maternal fever
2. Antepartum haemorrhage
3. Chorioamnionitis
4. Preterm labour (PTL)
5. Pre-existing diabetes
6. Preeclampsia
7. Cervical cerclage
8. Severe medical diseases
9. Allergy to progestin or placebo
10. Medical condition that might adversely interact with progesterone
11. Medical condition treated with systemic steroid
12. PPROM >48 hours prior presentation
13. Unsure gestational age

Fetal:
1. Fetal chromosomal abnormality
2. Fetal anomaly
3. Non reassuring surveillance (BPP < 4 / 10)
4. IUGR

Recruitment start date

01/03/2016

Recruitment end date

28/02/2017

Locations

Countries of recruitment

Saudi Arabia

Trial participating centre

Jeddah- Al Nozlah
Jeddah
21478
Saudi Arabia

Sponsor information

Organisation

Umm Al-Qura University

Sponsor details

Institute of Scientific Research and Revival of Islamic Heritage
Makkah
third ring road
Makkah
715
Saudi Arabia

Sponsor type

University/education

Website

http://uqu.edu.sa/page/en/242

Funders

Funder type

University/education

Funder name

Institute of Scientific Research and Revival of Islamic Heritage, Umm Al-Qura University (Saudi Arabia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/02/2016: The overall trial period has been updated from 01/07/2014 - 01/03/2015 to 01/06/2013 - 30/04/2017 and the recruitment period has been updated from 01/07/2014 - 01/03/2015 to 01/03/2016 - 28/02/2017.