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Completed

NCT Number: NCT03766594

Sildenafil Citrate in Early Unexplained Recurrent Pregnancy Loss

Recurrent unexplained spontaneous miscarriage (RSM) is defined as three consecutive pregnancy loss prior to 20 weeks from the last menstrual period. 1% to 2% of women experience RSM. Treatment of URSM is a challenging issue. The currently available lines of treatment according to simplicity of use, reliability and degree of invasiveness include corticosteroids, sildenafil citrate, aspirin, heparin and immunoglobulins (besides good antenatal care), but up to now there are no prospective randomized studies, powerful enough, to determine a significant difference between these therapeutic protocols, with any of the above mentioned pharmacological agents.

Sildenafil Citrate (Viagra®), a vasodilator, is also described as an anti-inflammatory agent. While improving uterine blood flow in the proliferative phase, NO may have detrimental effects at the level of the endometrium during the implantation window. The NO- mediated release of cytokines such as tumour necrosis factor- from activated natural killer cells has been implicated as a cause of implantation failure.

Based on these observations, this study attempts was made to study uterine arteries and sub-endometrial blood flow during the luteal phase in normal fertile women and in patients with Unexplained recurrent miscarriage

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Key information

Conditions

Miscarriage, Recurrent Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Ain SHams Maternity Hospital

Cairo, Abbaseya, 002, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 20-35 years.
  • BMI (20-30)
  • History of three or more successive unexplained recurrent miscarriage.
  • Normal uterine cavity by hystrography or hysteroscopy.
  • No luteal phase defects by progesterone > 10 ng.
  • Normal thyroid function (TSH, T3, T4)
  • Normal lupus anticoagulant measured by activated partial throbmoplastine time (32-43 seconds).
  • Normal anticardolipin (IgG < 20 gpl and IgM < 15 MPL measured by ELISA).
  • Normal anti thyroid antibodies.
  • Normal glucouse tolerance test.
  • Normal parental karyotyping.

Exclusion criteria

  • Age<20 or>35 year
  • BMI<20 or>30
  • Systemic diseases that might affect pregnancy such as diabetes or thyroid disorders or hypertension.
  • History of consanguinity.
  • Family history of chromosomal abnormalities (e.g. trisomy 21, trisomy 13, Turner's disease …etc.).
  • History of autoimmune diseases, eg: systemic lupus.
  • Congenital anomaly in uterine cavity as bicornate or septate uterus.
  • Luteal phase defect and corpus luteum insufficiency.
  • Uterine masses as fibroid or polyps.
  • Patient with patuoles os.
  • patient with antiphosphlipid syndrome.
  • Cigarette smoking and alcohol.

Treatment and study plan

sildenafil citrate

Drug

Respatio(R) 25mg tablets four times daily for 24 days preconceptionally starting first day of previous period

Folic Acid

Drug

Folic acid(R) 0.5mg tablets once daily for 3 months preconceptionally

Placebo oral tablet

Drug

Placebo tablet apparently identical to Respatio(R) 25mg tablets, taken four times daily for 24 days preconceptionally starting first day of previous period

Primary outcomes

  1. Miscarriage rate

    Time frame: 24 gestational weeks

    number of spontaneous/missed miscarriages among the participants in both groups

Secondary outcomes

  1. Uterine artery resistance index

    Time frame: At 24 gestational weeks

    Uterine artery resistance index assessed by uterine artery Doppler study in ongoing pregnancies of both groups

  2. Uterine artery pulsatility index

    Time frame: At 24 gestational weeks

    Uterine artery pulsatility index assessed by uterine artery Doppler study in ongoing pregnancies of both groups

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Preconceptional Sildenafil Citrate Treatment in Women With Early Unexplained Recurrent Pregnancy Loss: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 6, 2018
Registry last updated
Dec 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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