The Vaginal Progesterone and Cerclage

NCT02846909 | Completed Phase 2

• 1 other identifier: PCR
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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

Conditions

Abortion

Outcome Measures

Primary Outcomes (1)

• The frequency of spontaneous abortion before 28 weeks

  number of women aborted before 28 weeks

  14 weeks

Study Arms (2)

Vaginal progesterone group

ACTIVE COMPARATOR

Will receive progesterone pessaries 400 mg once daily vaginally

Drug: Progesterone

No progesterone group

NO INTERVENTION

Will receive nothing

Interventions

Progesterone DRUG

400mg progesterone pessaries

Vaginal progesterone group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

Related Publications (2)

• Eleje GU, Eke AC, Ikechebelu JI, Ezebialu IU, Okam PC, Ilika CP. Cervical stitch (cerclage) in combination with other treatments for preventing spontaneous preterm birth in singleton pregnancies. Cochrane Database Syst Rev. 2020 Sep 24;9(9):CD012871. doi: 10.1002/14651858.CD012871.pub2.

  PMID: 32970845 DERIVED

• Ali MK, Ahmed SE, Sayed GH, Badran EY, Abbas AM. Effect of adjunctive vaginal progesterone after McDonald cerclage on the rate of second-trimester abortion in singleton pregnancy: a randomized controlled trial. Int J Gynaecol Obstet. 2020 Jun;149(3):370-376. doi: 10.1002/ijgo.13148. Epub 2020 Apr 29.

  PMID: 32246762 DERIVED

MeSH Terms

Interventions

Progesterone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 23, 2016
• First Posted: July 27, 2016
• Study Start: April 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)