Investigation into the effectiveness of progesterone prevention of preterm labour in women who became pregnant by in vitro fertilisation (IVF)/ intra-cytoplasmic sperm injection (ICSI)
| ISRCTN | ISRCTN06959967 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06959967 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/06/2008
- Registration date
- 25/07/2008
- Last edited
- 30/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Mona Aboulghar
Scientific
Scientific
The Egyptian IVF-ET Center
3, St. 161 Hadaek Al Maadi
Maadi
Cairo
11431
Egypt
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effect of progesterone administration on the duration of pregnancy after in vitro fertilisation (IVF)/ intra-cytoplasmic sperm injection (ICSI): a prospective randomised study |
| Study objectives | Treatment with progesterone is emerging as the standard of care for prevention of preterm delivery in women at high risk for preterm birth. Randomised controlled trials (RCTs) have generally shown efficacy in reducing the rate of recurrent preterm delivery in women with singleton pregnancies who were at high risk for preterm labour and delivery. Most of the successful trials have employed 17-alpha-hydroxyprogesterone caproate, and one trial has reported positive results using progesterone vaginal suppositories. Very few trials of progestogens have been reported for women at risk for preterm delivery because of multiple gestations. |
| Ethics approval(s) | The Egyptian IVF-ET Center Ethics Committee. Date of approval: 17/06/2008 (ref: 4/2008) |
| Health condition(s) or problem(s) studied | Prevention of preterm labour after IVF/ICSI |
| Intervention | Intervention group: Natural progesterone will be administered in the form of natural Prontogest® 400 mg daily through the vaginal route (pessaries). Progesterone administration will continue until delivery. Control group: Standard care only Serum progesterone will be measured at start of trial (20 weeks gestation) and at 32 weeks gestation in all participants. |
| Intervention type | Other |
| Primary outcome measure | Delivery <37 weeks' gestation. |
| Secondary outcome measures | 1. Neonatal outcome 2. Incidence of prematurity 3. Admission to neonatal intensive care unit (ICU) 4. Complication of prematurity |
| Overall study start date | 01/07/2008 |
| Completion date | 30/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 302 |
| Key inclusion criteria | Healthy women who became pregnant after IVF/ICSI (singleton or twin). Randomisation will be carried out, on average, during the 20th week of gestation. |
| Key exclusion criteria | 1. Rupture of membranes 2. Smokers 3. Major known foetal anomalies 4. Uterine anomalies 5. Cervical cerclage 6. Treatment during this pregnancy with progesterone after 12 weeks' gestation (use up to 10 weeks' gestation is permitted) 7. Contraindications to tocolysis, including foetal distress, chorioamnionitis, preeclampsia, hemodynamic instability 8. Patients treated with oral beta adrenergics for asthma 9. Age <18 years |
| Date of first enrolment | 01/07/2008 |
| Date of final enrolment | 30/12/2009 |
Locations
Countries of recruitment
- Egypt
Study participating centre
The Egyptian IVF-ET Center
Cairo
11431
Egypt
11431
Egypt
Sponsor information
Marcyrl (Egypt)
Industry
Industry
Habib Scientific Office
Buildings Sheraton Square No. 1227
Building No. 8C
Cairo
-
Egypt
| Website | http://www.marcyrl.com |
|---|
Funders
Funder type
Hospital/treatment centre
This trial is funded mainly by the Egyptian IVF-ET Center (Egypt). The cost of medication is funded by Institut Biochimique SA (IBSA; Egypt).
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
