Recurrent Abortion
Conditions
Brief summary
Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation. The primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard pulsatility index (PI) and resistance index (RI), a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications.
Detailed description
Two groups of unexplained recurrent spontaneous abortion, each included 65 participants. scheduled randomly into; the study group received Sildenafil Citrate and Placebo group. The intervention started from day 21-23 of the cycle preceding spontaneous pregnancy and continued till the 12th-week of gestation. The primary outcome measure was the difference in the live birth between both groups. Secondary outcome measures were the differences between both groups regard PI and RI, a number of take-home babies, the reported side-effects of treatment and the pregnancy-related complications, e.g., preeclampsia and intrauterine growth restriction (\|IUGR).
Interventions
DRUGSildenafil Citrate vaginal suppositories
Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
DRUGPlacebo vaginal suppositories
Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
PROCEDUREUterine artery Doppler before treatment
Uterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy
PROCEDUREUterine artery Doppler after treatment
Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Sildenafil Citrate (SC) vaginal suppositories compared to Placebo vaginal suppositories.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Unexplained recurrent spontaneous abortion.
Exclusion criteria
* Abnormal uterine cavity. * Luteal phase insufficiency. * Endocrinal disorders, e.g., thyroid diseases, hyperprolactinemia, and Diabetes Mellitus. * Antiphospholipid syndrome. * Inherited or acquired thrombophilia. * Patients had renal, hepatic or cardiovascular diseases, hypertension, history of smoking, treated with vasodilators or sensitive to or developed severe side-effects with Sildenafil Citrate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference between both groups in live birth | Through study completion, an average of 9 months. | Live birth is defined as an ongoing pregnancy past to the 20th week of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uterine artery PI at cycle day 21-23 preceding pregnancy | At cycle day 21-23 preceding pregnancy | The difference between both groups regard PI at cycle day 21-23 preceding pregnancy |
| Uterine artery RI at cycle day 21-23 preceding pregnancy | At cycle day 21-23 preceding pregnancy | The difference between both groups regard RI at cycle day 21-23 preceding pregnancy |
| Uterine artery PI at the twelfth week of gestation | At the twelfth week of gestation. | The difference between both groups regard PI at the twelfth week of gestation |
| Uterine artery RI at the twelfth week of gestation | At the twelfth week of gestation. | The difference between both groups regard RI at the twelfth week of gestation |
Outcome results
None listed