Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02846909
Other study ID # PCR
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 1, 2017
Est. completion date April 1, 2019

Study information

Verified date August 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 242
Est. completion date April 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Progesterone
400mg progesterone pessaries

Locations

Country Name City State
Egypt Women Health Hospital - Assiut university Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The frequency of spontaneous abortion before 28 weeks number of women aborted before 28 weeks 14 weeks
See also
  Status Clinical Trial Phase
Terminated NCT00884403 - Gestational Age is Underestimated by Menstrual Dating Compared to Ultrasound Dating in Those Undergoing Abortion up to 20 Weeks
Completed NCT02083809 - Effects of Oxytocin on Bleeding Outcomes During Dilation and Evacuation N/A
Completed NCT00986921 - Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks N/A
Completed NCT00769912 - Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia Phase 3
Completed NCT00235534 - Trial of Immediate Versus Delayed Initiation of Oral Contraceptive Pills After Abortion N/A
Completed NCT06178224 - Determining Beta-hCG Levels in Patients Through Alternative Sample Types
Completed NCT04181021 - Evaluation of Values Clarification and Attitude Transformation Workshops on Abortion and Family Planning Service Provision and Client Experience N/A
Completed NCT01799252 - Side Effects and Adherence Associated With Doxycycline Use Following Medical Abortion N/A
Completed NCT00795314 - Propofol-butorphanol Anesthesia During Uterine Curettage Phase 4
Completed NCT02580175 - Surgical Evacuation of Abortion Under Ultrasonographic Guide Phase 2
Enrolling by invitation NCT03579550 - Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus N/A
Completed NCT01945385 - Impact of Video Intervention on Postabortal Uptake of Long Acting Reversible Contraception (LARC) N/A
Terminated NCT01436266 - Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion Phase 3
Completed NCT03227614 - Friends/Family in the Abortion Procedure Room (FAIR) N/A
Recruiting NCT03688581 - What is the Knowledge and Use of Emergency Contraception
Not yet recruiting NCT05471895 - Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion
Completed NCT05688228 - Voluntary Interruption of Pregnancy on Women's Sexuality
Completed NCT03136068 - Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation Phase 4
Completed NCT04651166 - Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation Phase 2
Recruiting NCT05645614 - Anxiety and Pain During Intervention for Abortion Under Local Anesthesia