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The Vaginal Progesterone and Cerclage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02846909
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Brief Summary:

Pregnancy loss in the second trimester is not uncommon. About 2-3% of pregnancies will be lost in the second trimester, which is much lower than in the first trimester. Once a pregnancy reaches 20 weeks gestation, less than 0.5% will end in a fetal demise.

Congenital fetal abnormalities and maternal anatomic factors as immunologic factors, infection, and thrombophilia should be considered; however, a reason and its result connection may be difficult to be established.

Cervical incompetence means that the cervix is weak and unable to remain closed during the pregnancy. While cerclage may provide a degree of support to a 'weak' cervix, its role in maintaining the cervical length and the endocervical mucus plug as a mechanical barrier to ascending infection may be more important.

Cervical cerclage is performed usually in women with a history of mid-trimester abortion or spontaneous preterm birth due to cervical 'incompetence', with the aim of preventing recurrent loss.

Cerclage is a commonly performed as a prophylactic intervention used by most obstetricians despite the absence of a well-defined population for whom there is clear evidence of benefit. Furthermore, there is little consensus on the optimal cerclage technique and timing and type of suture placement.

The Progesterone is known to have an inhibitory action on uterine contractility and is thought to play a main role in the maintenance of pregnancy until term. Progesterone is also able to modify the ultrastructural organisation of the myometrium by inhibiting the gap junctions, and preventing muscular contraction.

Different routes of administration of progesterone have been described in the literature. These include weekly intramuscular injections from 16 to 20 weeks through to 36 weeks and daily vaginal progesterone suppositories from 24 weeks to 34 weeks of gestation.

A recently published Cochrane review further confirmed the beneficial effects of progesterone in infant health following administration in women considered to be at increased risk of preterm birth due either to past history of preterm birth or when a short cervix was identified on ultrasound.

However; most of these published studies have been conducted to test the effect of progestational agents for the prevention of preterm labor not miscarriage.

Doppler ultrasonography is use to evaluate blood flow. In the field of perinatology, Doppler ultrasonography has been used to assess fetal well-being, especially in intra-uterine growth retardation and fetal anemia, and it plays an important role in managing of these conditions


Condition or disease Intervention/treatment Phase
Abortion Drug: Progesterone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Adjunctive Use of Vaginal Progesterone After Cerclage on Prevention of 2nd Trimester Miscarriage
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

Arm Intervention/treatment
Active Comparator: Vaginal progesterone group
Will receive progesterone pessaries 400 mg once daily vaginally
Drug: Progesterone
400mg progesterone pessaries

No Intervention: No progesterone group
Will receive nothing



Primary Outcome Measures :
  1. The frequency of spontaneous abortion before 28 weeks [ Time Frame: 14 weeks ]
    number of women aborted before 28 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age from 20 - 35 years old.
  • Pregnant from (12- 14 weeks) gestation.
  • Singleton pregnancy.
  • The pregnant women who have a history of second trimester pregnancy loss with painless cervical dilatation or have prior cerclage placement for cervical insufficiency or have a history of spontaneous preterm.

Exclusion Criteria:

  • Multiple gestations.
  • Congenital fetal malformation in the current pregnancy.
  • Women with history of thromboembolism or bleeding disorders.
  • Uncontrolled diabetes mellitus.
  • Chromosomal abnormalities affecting one of the couples.
  • Women refuse to participate in the study
  • Antiphospholipid syndrome

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): NCT02846909


Locations
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Egypt
Women Health Hospital - Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mohammed Khairy Ali, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT02846909    
Other Study ID Numbers: PCR
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs