Placenta Accreta
Conditions
Keywords
Placenta accreta, Resective reconstructive treatment, Hysterectomy
Brief summary
Currently, Placenta Accreta Spectrum (PAS) has two treatment options: hysterectomy (completely removing the uterus) and partial myometrial resection (resecting the part of the uterus affected by this pathology). The present study is a feasibility study of a multicenter, randomized controlled clinical trial to be carried out in 3 health institutions. Patients who meet the inclusion criteria, after signing the informed consent, will be taken to the surgical procedure and before the start of the procedure they will be randomized to one of the two interventions, hysterectomy or partial myometrial resection, intra-surgical clinical outcomes will be explored and a follow-up will be carried out during the immediate post-surgical period (72 hours), in 7 to 12 days and at 42 days postpartum. A sample size of 60 patients is estimated among the 3 health institutions, with an approximate duration of the study of 24 months.
Detailed description
Placenta accreta spectrum is a serious condition associated with significant maternal morbidity and even mortality. The recommended treatment is hysterectomy. An alternative is 1-step conservative surgery, which involves the en bloc resection of the myometrium affected by placenta accreta spectrum along with the placenta, followed by uterine reconstruction. Currently, there are no studies comparing the 2 techniques in the setting of a randomized controlled trial. We performed a prospectively registered multicenter randomized controlled trial comparing hysterectomy with 1-step conservative surgery. The aim was to collect feasibility and clinical outcomes of the 2 techniques in women assigned to hysterectomy or 1step conservative surgery. In addition to assessing participants' willingness to be randomized, we also collected data on intraoperative blood loss, transfusion requirement, serious adverse event, and other clinical outcomes. Sixty women with strong antenatal suspicion of placenta accreta spectrum were assigned randomly to either hysterectomy (n=31) or 1-step conservative surgery (n=29).
Interventions
PROCEDUREHysterectomy
Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients
PROCEDUREPartial Myometrial Resection
Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesico-uterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.
Sponsors
Fundacion Clinica Valle del Lili
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study as it is not possible to conceal the surgical procedure for each arm from the operator (Treating Physician) or from the participant
Intervention model description
Eligible women will receive complete information about the study. If they agree to participate in it, they will sign the informed consent for both interventions: hysterectomy and partial myometrial resection. The final modality of intervention will be decided at randomization prior to the start of the surgical procedure. If the diagnosis of PAS is confirmed by observing the clinical criteria endorsed by the International Federation of Gynecology and Obstetrics (FIGO), the patient's participation in the study is confirmed and the surgical procedure defined by randomization is continued, that is, one of the two arms of the study: Primary hysterectomy or Partial myometrial resection.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women over 18 years of age. * History of previous cesarean section and anterior placenta previa * Patients with prenatal diagnosis by ultrasound or MRI of PAS, regardless of the suspected degree of severity of the disease. * Requirement for surgical management of placental accreta on a scheduled basis. * Patients without active vaginal bleeding in the period immediately before surgery (Patients entering the operating room without active bleeding).
Exclusion criteria
* Women without previous living children.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study. | 6 weeks | Number of patients who agree to participate, out of the total number of eligible patients |
| Screening Failure Percentage | During surgery | Percentage of patients who entered the study but did not present macroscopic findings of placenta accreta spectrum during laparotomy. |
| Percentage of Patients With Crossover Between Assigned Study Arms. | During surgery | All patients had been randomized before surgery to a certain procedure; however, after performing intraoperative staging, it was identified that some women did not have signs of PAS (7 patients with false positive prenatal diagnosis, randomized to hysterectomy), so they were managed with OSCS, and that some women did not meet the criteria to perform OSCS (9 patients randomized to OSCS), so they were managed with hysterectomy; |
| Number of Participants Who Completed the Follow-up Evaluation. | 42 days postpartum | Number of participants who completed follow-up at 42 days postpartum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Met at Least 1 Near Miss Criterion | Up to 42 days postpartum | Situation or indicator that almost led to a serious adverse event but did not actually result in harm. For this study, the event was cardiac arrest with successful resuscitation. |
| Number of Patients Who Had Bladder Injuries | Up to 42 days postpartum | Number of patients who had intraoperative bladder injuries. |
| Maternal Death | 6 weeks | Number of maternal deaths during the study period |
| Number of Patients Who Were Admitted to the Intensive Care Unit. | Up to 42 days postpartum | Number of patients that required management in the Intensive Care Unit |
| Number of Days of Postoperative Hospital Stay. | Up to 42 days postpartum | Number of days of hospital stay after index surgery |
| Number of Patients Who Need Surgical Reoperation. | Up to 42 days postpartum | Number of patients who need surgical reoperation after index surgery |
| Intra-surgical Bleeding Volume | During surgery | Surgical bleeding calculated in milliliters |
| Blood Component Transfusion Requirement | Up to 42 days postpartum | If during hospitalization the patient required transfusion of some type of blood component |
| Median Transfusion of Red Blood Cell Units (RBCU) | Up to 42 days postpartum | Median number of units of red blood cells transfused |
Countries
Colombia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hysterectomy An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients | 31 |
| Partial Myometrial Resection The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesicouterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated. | 29 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet the requirements for OSCS after intraoperative staging. | 0 | 9 |
| Overall Study | Patients without signs of PAS in the intraoperative staging. US false positive | 7 | 2 |
Baseline characteristics
| Characteristic | Hysterectomy | Partial Myometrial Resection | Total |
|---|---|---|---|
| Age, Customized Maternal age (years) | 33.13 years STANDARD_DEVIATION 4.26 | 33.45 years STANDARD_DEVIATION 4.56 | 33.28 years STANDARD_DEVIATION 4.38 |
| Antepartum vaginal bleeding | 1 Participants | 0 Participants | 1 Participants |
| Body mass index 18-24 | 10 kg/m^2 | 8 kg/m^2 | 18 kg/m^2 |
| Body mass index 25-29 | 13 kg/m^2 | 12 kg/m^2 | 25 kg/m^2 |
| Body mass index ≥30 | 8 kg/m^2 | 9 kg/m^2 | 17 kg/m^2 |
| Comorbidity Gestational diabetes | 0 participants | 1 participants | 1 participants |
| Comorbidity Hypertensive disorder | 1 participants | 1 participants | 2 participants |
| Diagnostic method of PAS Ultrasound | 25 Participants | 21 Participants | 46 Participants |
| Diagnostic method of PAS Ultrasound and Magnetic Resonance | 6 Participants | 8 Participants | 14 Participants |
| Gestational age at birth | 35.00 weeks | 35.00 weeks | 35.00 weeks |
| Gestational age at the time of diagnosis of PAS | 33.10 weeks | 31.00 weeks | 32.75 weeks |
| Number of previous cesarean sections 1 | 18 Participants | 14 Participants | 32 Participants |
| Number of previous cesarean sections 2 | 13 Participants | 13 Participants | 26 Participants |
| Number of previous cesarean sections ≥3 | 0 Participants | 2 Participants | 2 Participants |
| Number of previous dilatation curettage 0 | 24 Participants | 21 Participants | 45 Participants |
| Number of previous dilatation curettage 1 | 7 Participants | 5 Participants | 12 Participants |
| Number of previous dilatation curettage ≥2 | 0 Participants | 3 Participants | 3 Participants |
| Number of previous pregnancies 1 | 9 number of previous pregnancies | 7 number of previous pregnancies | 16 number of previous pregnancies |
| Number of previous pregnancies 2 | 16 number of previous pregnancies | 8 number of previous pregnancies | 24 number of previous pregnancies |
| Number of previous pregnancies ≥3 | 6 number of previous pregnancies | 14 number of previous pregnancies | 20 number of previous pregnancies |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex/Gender, Customized Female | 31 Participants | 29 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 27 |
| other Total, other adverse events | 0 / 33 | 0 / 27 |
| serious Total, serious adverse events | 3 / 33 | 5 / 27 |
Outcome results
Primary
Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study.
Number of patients who agree to participate, out of the total number of eligible patients
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study. | 60 Participants |
Primary
Number of Participants Who Completed the Follow-up Evaluation.
Number of participants who completed follow-up at 42 days postpartum
Time frame: 42 days postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Number of Participants Who Completed the Follow-up Evaluation. | 31 Participants |
| Partial Myometrial Resection | Number of Participants Who Completed the Follow-up Evaluation. | 29 Participants |
Primary
Percentage of Patients With Crossover Between Assigned Study Arms.
All patients had been randomized before surgery to a certain procedure; however, after performing intraoperative staging, it was identified that some women did not have signs of PAS (7 patients with false positive prenatal diagnosis, randomized to hysterectomy), so they were managed with OSCS, and that some women did not meet the criteria to perform OSCS (9 patients randomized to OSCS), so they were managed with hysterectomy;
Time frame: During surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Percentage of Patients With Crossover Between Assigned Study Arms. | 7 Participants |
| Partial Myometrial Resection | Percentage of Patients With Crossover Between Assigned Study Arms. | 9 Participants |
Primary
Screening Failure Percentage
Percentage of patients who entered the study but did not present macroscopic findings of placenta accreta spectrum during laparotomy.
Time frame: During surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Screening Failure Percentage | 7 Participants |
| Partial Myometrial Resection | Screening Failure Percentage | 2 Participants |
Secondary
Blood Component Transfusion Requirement
If during hospitalization the patient required transfusion of some type of blood component
Time frame: Up to 42 days postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Blood Component Transfusion Requirement | 19 Participants |
| Partial Myometrial Resection | Blood Component Transfusion Requirement | 17 Participants |
Secondary
Intra-surgical Bleeding Volume
Surgical bleeding calculated in milliliters
Time frame: During surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Eligible Patients | Intra-surgical Bleeding Volume | 1500 mL |
| Partial Myometrial Resection | Intra-surgical Bleeding Volume | 1740 mL |
Secondary
Maternal Death
Number of maternal deaths during the study period
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Maternal Death | 0 Participants |
| Partial Myometrial Resection | Maternal Death | 0 Participants |
Secondary
Median Transfusion of Red Blood Cell Units (RBCU)
Median number of units of red blood cells transfused
Time frame: Up to 42 days postpartum
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Eligible Patients | Median Transfusion of Red Blood Cell Units (RBCU) | 3 Number of RBCU |
| Partial Myometrial Resection | Median Transfusion of Red Blood Cell Units (RBCU) | 2 Number of RBCU |
Secondary
Number of Days of Postoperative Hospital Stay.
Number of days of hospital stay after index surgery
Time frame: Up to 42 days postpartum
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Eligible Patients | Number of Days of Postoperative Hospital Stay. | 4 Days |
| Partial Myometrial Resection | Number of Days of Postoperative Hospital Stay. | 5 Days |
Secondary
Number of Patients Who Had Bladder Injuries
Number of patients who had intraoperative bladder injuries.
Time frame: Up to 42 days postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Number of Patients Who Had Bladder Injuries | 2 Participants |
| Partial Myometrial Resection | Number of Patients Who Had Bladder Injuries | 1 Participants |
Secondary
Number of Patients Who Met at Least 1 Near Miss Criterion
Situation or indicator that almost led to a serious adverse event but did not actually result in harm. For this study, the event was cardiac arrest with successful resuscitation.
Time frame: Up to 42 days postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Number of Patients Who Met at Least 1 Near Miss Criterion | 1 Participants |
| Partial Myometrial Resection | Number of Patients Who Met at Least 1 Near Miss Criterion | 0 Participants |
Secondary
Number of Patients Who Need Surgical Reoperation.
Number of patients who need surgical reoperation after index surgery
Time frame: Up to 42 days postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Number of Patients Who Need Surgical Reoperation. | 1 Participants |
| Partial Myometrial Resection | Number of Patients Who Need Surgical Reoperation. | 1 Participants |
Secondary
Number of Patients Who Were Admitted to the Intensive Care Unit.
Number of patients that required management in the Intensive Care Unit
Time frame: Up to 42 days postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Patients | Number of Patients Who Were Admitted to the Intensive Care Unit. | 4 Participants |
| Partial Myometrial Resection | Number of Patients Who Were Admitted to the Intensive Care Unit. | 3 Participants |