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Status unknownNCT05560984Updated Oct 10, 2022

Cervical Internal os Plasty in Management of Placenta Previa and Focal Accreta

An interventional study of cervical internal os plasty in Cervical IO Plasty in Management of Placenta Previa, sponsored by Zagazig University. Status unknown. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-10-10.

Sponsored by Zagazig University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

Aim of the work:

Better management \& reducing hemorrhage and complication in patients placenta previa and focal accreta .

Read the detailed description

Placenta accrete spectrum (PAS) is one of the major causes of massive obstetric hemorrhage and life-threatening complication of pregnancy. Patients with placenta previa may develop severe postpartum hemorrhage especially when coinciding with placenta accreta, it may be associated with potentially life-threatening maternal hemorrhage after removal of the placenta due to its incomplete separation and massive bleeding from the placental attachment site. Normally, the placenta adheres only to the decidua basalis, thus it separates smoothly from the wall of the uterus after delivery. Placenta accreta (PA) exists when the chorionic villi penetrate through the decidua basalis into the myometrium . The steady rise of cesarean section (CS) delivery rates in recent years combined with increasing maternal age, multiparity, placenta previa, prior uterine surgeries or curettage, and Asherman syndrome is associated with increasing incidence of PAS. In a systematic review, the rate of placenta accreta spectrum (PAS) increase from 0.3% in women with one previous cesarean delivery to 6.74% for women with five or more cesarean deliveries . In the setting of a placenta previa and one or more previous cesarean deliveries, the risk of PAS dramatically increases. For women with placenta previa, the risk of placenta accrete is 3%, 11%, 40%, 61%, 67%, for the first, second, third, fourth, and fifth or more cesareans, respectively. Placenta previa and placenta accrete carry significant maternal and fetal morbidity and mortality. The maternal mortality in women with PA may reach as high as 7-10 % . Acute torrential bleeding, massive blood transfusion, hysterectomy, and even the death of the woman can occur during cesarean delivery because of placenta previa increta. As intraoperative bleeding from PASin the lower uterine segment is often vast, massive, dramatically quick and difficult to stop after removal of the placenta resulting in severe maternal morbidity and mortality it is of outmost importance to have a pre-planned approach to this surgical challenge that is effective and swift. The differences between the lower and upper segments of the uterus are the main cause for postpartum hemorrhage associated with placenta accreta spectrum. The lower uterine segment is highly vascular and slower to retract than upper segment. Surgical intervention is indicated when uterotonic medications fail to control blood loss . The optimal management of PAS remains controversial. However, in practice, the conservative methods sometimes are incapable of stopping the bleeding from the placental attachment site. Moreover, the success of some surgical techniques, such as blood vessel ligation, has been associated with the experience and proficiency of the obstetricians, and in many hospitals, the conditions do not exist for performing perioperative temporary balloon occlusion of the internal iliac arteries and uterine arterial embolization. If these procedures prove invalid, hysterectomy is performed to ensure maternal survival. Currentseveral clinical hemostatic techniques have been described in the literature for controlling massive bleeding associated with placenta previa cesarean sections, including uterine packing with gauze , balloon tamponades,superposition sutures,hemostatic multiple square suturing, insertion of parallel vertical compression sutures , and so on when the bleeding is not so severe. If necessary, obstetricians often attempt to employ B-Lynch sutures, and embolization or ligation of the uterine and internal iliac arteries ,but there is a wide variation in the success rate of these maneuvers . There is lack of consensus on the optimal uterine sparing surgical approach to reduce intraoperative bleeding if the placenta is partially separated. Whilst electing for timely hysterectomy may be recommended and lifesaving, this may not be ideal for women wishing to preserve their fertility and uterine sparing alternative interventions are highly needed.

02

Conditions studied

  • Cervical IO Plasty in Management of Placenta Previa
03

In context

Lead sponsor

Zagazig University is the lead sponsor of 457 studies on the registry; 77 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All the participants with placent aprevia and focal accreta will be diagnosed by ultrasound and color Doppler.
  • One or more previous cesarean section.
  • Gestational age of 32 - 38 weeks.
  • Desire to preserve the uterus

Exclusion criteria

Exclusion Criteria:

  • Diffuse placenta accreta.
  • Placenta percreta.
  • Presence of uncontrollable hemorrhage
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    study population

    Women with previous one or more cesarean sections with placenta previa and focal accrete

    Combination Product: cervical internal os plasty

Interventions

  • Combination productcervical internal os plasty

    A long Allis forceps will be passed through the uterine incision and used to grasp the anterior lip of the cervix, pulling the cervix upwards into the uterine cavity. An assistant sometimes needs to elevate the cervix upwards from the vaginal aspect. The anterior lip of the cervix will be sutured to the anterior wall of the lower uterine segment using two or three simple interrupted absorbable stitches (Vicryl or Vicryl rapid no. 0). This aids to compress the bleeding sites of the placental bed and support the very thin lower uterine segment. If the placenta was implanted posteriorly and the bleeding areas will be mainly from the posterior wall of the uterus, the same procedure could be repeated using the posterior lip of the cervix. A Hegar dilator (size 12) will be inserted in a retrograde manner from the abdominal aspect toensure patency of the cervical canal .

06

What researchers measure

Primary outcomes

  1. amount of intra-operative blood loss (mL)

    Time frame: 5 months

Secondary outcomes

  1. Number of patients develop postpartum hemorrhage (500 mL or greater).

    Time frame: 5 months

  2. Number of patients need blood transfusion

    Time frame: 5 months

  3. Number of patients need hysterectomy

    Time frame: 5 months

  4. Mean duration of postoperative hospital stay (days).

    Time frame: 5 months

  5. Time needed to perform the technique (minutes).

    Time frame: 5 months

  6. Number ot participants develop complications: •Urinary bladder injury •Wound infection •Postoperative fever.

    Time frame: 5 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Jauniaux E, Chantraine F, Silver RM, Langhoff-Roos J; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Epidemiology. Int J Gynaecol Obstet. 2018 Mar;140(3):265-273. doi: 10.1002/ijgo.12407. No abstract available. PubMed 29405321 ↗
  • Kondoh E. Expectant Management of Placenta Accreta Spectrum Disorders. Surg J (N Y). 2021 Jun 3;7(Suppl 1):S2-S6. doi: 10.1055/s-0040-1722240. eCollection 2021 Dec. PubMed 35036541 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05560984
Lead sponsor
Zagazig University
Responsible party
Al Shymaa Mohamed Abd El Hadi (Assistant lecturer,obstetrics and gynecology department, Zagazig University) — Principal investigator
First posted
Sep 30, 2022
Start date
Oct 2022 (estimated)
Primary completion
Jan 2023 (estimated)
Completion
Feb 2023 (estimated)
Last update
Oct 10, 2022

Study contacts

Al Shymaa Mohamed
Contact
obgyns90@gmail.com
01098721121
Basem Hamed
Contact
01004132040

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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